investor presentation first six months of 2017 - novo · pdf file• region china grew by...
TRANSCRIPT
Slide 1
5,05
4,10
3,50
4,72
11,82 11,82
Investor presentation
First six months of 2017
Manato Ohara, diagnosed with type 1 diabetes Kanagawa, Japan
Slide 2
5,05
4,10
3,50
4,72
11,82 11,82
Agenda
Investor presentation First six months of 2017
Highlights and key events
R&D update
Financials and outlook
Sales update
Slide 3
5,05
4,10
3,50
4,72
11,82 11,82
Forward-looking statements
Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including the company’s Annual Report 2016 and Form 20-F, which are both filed with the SEC in February 2017 in continuation of the publication of the Annual Report 2016, and written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as ‘believe’, ‘expect’, ‘may’, ‘will’, ‘plan’, ‘strategy’, ‘prospect’, ‘foresee’, ‘estimate’, ‘project’, ‘anticipate’, ‘can’, ‘intend’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to:
• Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk’s products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto
• Statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures
• Statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and
• Statements regarding the assumptions underlying or relating to such statements.
These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this presentation, could cause actual results to differ materially from those contemplated in any forward-looking statements.
Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recall, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk’s products, introduction of competing products, reliance on information technology, Novo Nordisk’s ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees, and failure to maintain a culture of compliance.
Please also refer to the overview of risk factors in ‘Risk Management’ on pp 40-43 of the Annual Report 2016.
Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this presentation, whether as a result of new information, future events or otherwise.
Important drug information
• Victoza® (liraglutide 1.2 mg & 1.8 mg) is approved for the management of type 2 diabetes only
• Saxenda® (liraglutide 3 mg) is approved in the US and EU for the treatment of obesity only
Investor presentation First six months of 2017
Slide 4
5,05
4,10
3,50
4,72
11,82 11,82
Highlights – First six months of 2017
Investor presentation First six months of 2017
Research and Development • Semaglutide in obesity demonstrated an adjusted average weight loss of 13.8% with the highest dose in phase 2 trial • The US application for including SWITCH trials in the Tresiba® label to be reviewed in the context of the DEVOTE trial • Positive 17-2 vote from FDA Advisory Committee that Victoza® reduces the cardiovascular risk in people with type 2 diabetes • Victoza® approved in the EU as the only GLP-1 with a label to include prevention of cardiovascular events
Sales development • Sales increased by 4% in Danish kroner and 3% in local currencies
• North America Operations grew by 2% and accounted for 32% share of growth in local currencies • International Operations grew by 5% and accounted for 68% share of growth in local currencies
• Region Europe grew by 4% in local currencies • Region China grew by 7% in local currencies • Region AAMEO grew by 4% in local currencies
• Tresiba® grew 149% and Victoza® grew 18% in local currencies
Financials • Operating profit increased by 8% in Danish kroner and by 6% in local currencies • Diluted earnings per share increased by 6% to 8.07 DKK per share. • 2017 financial outlook:
• Sales growth is now expected to be 1% to 3% in local currencies (now around 3% lower reported) • Operating profit growth is now expected to be 1% to 5% in local currencies (now around 4% lower reported)
• An interim dividend of DKK 3.00 per share of DKK 0.20 will be paid in August 2017
Slide 5
5,05
4,10
3,50
4,72
11,82 11,82
Growth analysis – First six months of 2017
Sales growth is primarily driven by the US, Region Europe and Region China
Investor presentation First six months of 2017
Sales as reported – First six months of 2017
Sales of DKK 57.1 billion (+4%)
Local currencies Growth Share of growth
North America Operations 2% 32%
Hereof USA 2% 28%
International Operations 5% 68%
Region Europe 4% 24%
Region AAMEO 4% 13%
Region China 7% 22%
Region Japan & Korea 1% 1%
Region Latin America 9% 8%
Total sales 3% 100%
Region AAMEO +3%
Region China +5%
Region Japan & Korea
+3%
Region Europe +3%
North America Operations
+5%
Region Latin America +14%
AAMEO: Africa, Asia, Middle East & Oceania
18%
11%
10%
5% 3%
53%
Slide 6
5,05
4,10
3,50
4,72
11,82 11,82
Local currencies Growth Share of growth
New-generation insulin1 155% 144%
Modern insulin (1%) (20%)
Human insulin (4%) (13%)
Victoza® 18% 100%
Other diabetes care2 (2%) (3%)
Total diabetes care 9% 208%
Obesity (Saxenda®) 90% 32%
Diabetes and obesity care total 10% 240%
Haemophilia3 (2%) (8%)
Human growth hormone products (28%) (74%)
Other biopharmaceuticals4 (53%) (58%)
Biopharmaceuticals (20%) (140%)
Total 3% 100%
Sales growth is driven by new-generation insulin and Victoza®
Investor presentation First six months of 2017
Sales as reported – First six months of 2017 Growth analysis – First six months of 2017
1 Comprises Tresiba®, Xultophy®, Ryzodeg® and Fiasp®
2 Primarily NovoNorm® and needles 3 Comprises NovoSeven®, NovoEight® and NovoThirteen®
4 Primarily Vagifem® and Activelle®
Other biopharmaceuticals (52%)
7% Haemophilia
(1%)
11%
Diabetes care +10%
79%
3%
Human growth hormone
(27%)
Sales of DKK 57.1 billion (+4%)
Obesity +98% 2%
9%
6% 2%
81%
Slide 7
5,05
4,10
3,50
4,72
11,82 11,82
0%
20%
40%
60%
0 10 20 30 40 50
0%
10%
20%
30%
40%
0 10 20 30 40 50
Basal insulin market penetration with Tresiba® is supported by Xultophy® launches
Investor presentation First six months of 2017
Combined value share of Tresiba® and Xultophy® in selected countries
Months from launch1
Switzerland Sweden Greece
56%
41%
21%
Tresiba® share
Tresiba® value share of basal insulin segment in selected countries outside the US
Note: Limited IMS coverage in India Source: IMS Monthly value figures, May 2017
Months from launch
Mexico
Switzerland
Japan Denmark
Netherlands
Brazil
UK India
Greece Italy
Spain
12%
5%
22%
30%
24%
10% 13%
28%
41%
28%
20%
Source: IMS Monthly value figures, May 2017 1 Switzerland, Sweden and Greece: Months from Tresiba® launch. France: Months from Xultophy® launch (Tresiba® is not launched in France).
France (Xultophy® only)
10%
19%
Argentina
Slide 8
5,05
4,10
3,50
4,72
11,82 11,82
Weekly TRx volume market shares in the US
Increasing total basal insulin market share in the US
Investor presentation First six months of 2017
Tresiba® launch in the US
• Tresiba® New-to-Brand Prescriptions market share of around 12%
• Tresiba® TRx volume market share is now 8.5% and Novo Nordisk expects to reach a TRx volume market share of around 10% by the end of 2017
• The uptake of Tresiba® is driven by strong penetration in the commercial channel, partly offset by lower sales in Medicare part D
• Tresiba® has wide formulary access of around 70% access for patients in commercial channels and Medicare part D combined in 2017
Basal volume TRx MS
Levemir® NN Total Basal Tresiba® glargine U100 glargine U300 biosimilar glargine U100
Source: IMS weekly Xponent Plantrak (excludes Medicaid), 21 July 2017
Note: The graph does not show NPH, which accounts for the residual market share Source: IMS weekly Xponent Plantrak (excludes Medicaid), 21 July 2017 TRx volume: Insulin volume in mega units (MU) associated with total number of prescriptions; MS: Market share
July 2017
32%
23%
9% 8% 4%
50%
0%
10%
20%
30%
40%
50%
60%
70%
01/01/2016Jan 2016
Slide 9
5,05
4,10
3,50
4,72
11,82 11,82
0%
20%
40%
60%
80%
100%
0.00
0.05
0.10
0.15
0.20
0.25
0.30
0.35
0.40
Investor presentation First six months of 2017
Continued GLP-1 market volume growth of more than 25% in the US
US GLP-1 market development
Source: IMS NPA monthly, May 2017
US GLP-1 volume market share
Total TRx Growth rate
exenatide Victoza®
albiglutide dulaglutide
MAT GLP-1 TRx (million)
GLP-1 TRx market share
MAT volume growth rate
May 2017
May 2014
0%
5%
10%
15%
20%
25%
30%
35%
0
2
4
6
8
10
Mill
ions
May 2014
May 2017
US GLP-1 market monthly TRx GLP-1 TRx volume (million)
May 2014
May 2017
exenatide Victoza®
albiglutide dulaglutide
46%
34%
16%
4%
Slide 10
5,05
4,10
3,50
4,72
11,82 11,82
Current level of unrestricted market access for key Novo Nordisk diabetes products in the US
Investor presentation First six months of 2017
Unrestricted market access
Broad market access across the diabetes portfolio expected to be maintained in the US for 2018
Source: FingerTip Formulary, May 2017 Note: Unrestricted access excludes prior authorisation, step edits and other restrictions
US formulary negotiations and 2018 pricing
• For 2018, formulary negotiations with pharmacy benefit managers and managed care organisations in the US are progressing
• Subject to the final outcome of these negotiations, average prices after rebates are expected to be lower compared with the levels in 2017, predominantly driven by the basal insulin segment
• Market access is anticipated to remain broadly unchanged across the diabetes portfolio at a level similar to 2017
Commercial Medicare part D
0%
20%
40%
60%
80%
100%
Victoza® Levemir Tresiba Novolog Victoza® Levemir® Tresiba® NovoLog®
Slide 11
5,05
4,10
3,50
4,72
11,82 11,82
-20%
-15%
-10%
-5%
0%
Key results and next steps
Semaglutide in obesity demonstrated an adjusted average weight loss of 13.8% with the highest dose in phase 2 trial
2 Includes patients who completed treatment. From a mean baseline weight of around 111 kg an average weight loss up to 17.8 kg was observed. 3 Includes people discontinuing treatment in the study.
Investor presentation First six months of 2017
Next steps: Phase 3 clinical trial programme to be initiated in the first half of 2018
1 Inclusion criteria: Male or female, age ≥18 yrs, BMI ≥30 kg/m2, stable body weight, preceding failed dietary effort, no diabetes (HbA1c<6.5%), no history of pancreatitis (acute or chronic) or multiple endocrine neoplasia Note: All treatment arms are adjunct to diet and exercise sc: Subcutaneous; QD: Once-daily
Semaglutide in obesity phase 2 trial design
Semaglutide 0.05-0.4 mg. sc QD
Placebo 3.0 mg. sc QD
957 people with obesity without diabetes1
Average weight loss
-13.8%
-2.3%
Patients completed2
Adjusted for discontinuation3 Placebo
Placebo 0.05-0.4 mg. sc QD
Liraglutide 3.0 mg. sc QD
52 weeks
-16.2%
Slide 12
5,05
4,10
3,50
4,72
11,82 11,82
• REBINYN® approved in the US and Refixia® approved in the EU (N9-GP)
• New Drug Application for N9-GP submitted to the Japanese Ministry of Health
• Positive results from pivotal phase 3a trial with long-acting growth hormone somapacitan (NN8640)1
Key development milestones reached
FDA: Food and Drug Administration; CV: Cardiovascular 1 Indication in adult growth hormone deficiency
• Data from the DEVOTE trial submitted in the US and the EU for a label update of Tresiba®
• The US application for including SWITCH trials in the Tresiba® label to be reviewed in the context of the DEVOTE trial
• Victoza® approved in the EU as the only GLP-1 with a label to include prevention of CV events
• Positive 17-2 vote from FDA Advisory Committee that Victoza® reduces the cardiovascular risk in people with type 2 diabetes
• EU label update for Saxenda® based on the LEADER trial approved by the European Commission
Diabetes
Obesity
Biopharm
Investor presentation First six months of 2017
Slide 13
5,05
4,10
3,50
4,72
11,82 11,82
Significant regulatory news flow in 2017
Investor presentation First six months of 2017
Project Q1 2017 Q2 2017 Q3 2017 Q4 2017
1 It is Novo Nordisk’s assessment that FDA plans to review the SWITCH studies in the context of the data from the recently submitted DEVOTE trial. Feedback expected by the end of Q1 2018. 2 Study conducted in adult growth hormone disorder
Diabetes Haemophilia Growth disorders
Tresiba®
Victoza®
Once-weekly semaglutide
N9-GP
Fast-acting insulin aspart EU approval
Somapacitan
Concizumab
Results available Regulatory milestone
US resubmission
US approval
REAL 1 phase 3a data2
SUSTAIN 7 phase 3b data
US regulatory decision
LEADER US reg. decision
Obesity
Semaglutide obesity Phase 2 data
√
Japan submission CHMP opinion
Japan submission
US regulatory decision
US & EU submission of DEVOTE data1
√
√
EU SWITCH approval √
CHMP: Committee for Medicinal Products for Human Use in the EU
Phase 1 data √
√
√
LEADER EU approval √
√
√
√
EU approval √
Slide 14
5,05
4,10
3,50
4,72
11,82 11,82
Financial results – first six months 2017
Investor presentation First six months of 2017
DKK million H1 2017 H1 2016 Change
(reported DKK) Change
(local currency)
Sales 57,090 54,671 4% 3%
Gross profit 48,430 46,392 4% 3% Gross margin 84.8% 84.9%
Sales and distribution costs 13,548 13,608 (0%) (1%) Percentage of sales 23.7% 24.9%
Research and development costs 6,703 6,635 1% 1% Percentage of sales 11.7% 12.1%
Administration costs 1,770 1,781 (1%) (2%) Percentage of sales 3.1% 3.3%
Other operating income, net 467 438 7% 5%
Operating profit 26,876 24,806 8% 6% Operating margin 47.1% 45.4%
Financial items (net) (1,229) (251) 390%
Profit before income tax 25,647 24,555 4%
Income taxes 5,540 5,132 8% Effective tax rate 21.6% 20.9%
Net profit 20,107 19,423 4%
Diluted earnings per share (DKK) 8,07 7,63 6%
Slide 15
5,05
4,10
3,50
4,72
11,82 11,82
80
85
90
95
100
105
110
115
120
The US dollar has depreciated 8% since Q1 2017 report, leading to a 4%1 negative operating profit impact
Investor presentation First six months of 2017
Hedged c
urr
encie
s
Index (
1 J
an 2
016=
100)
CNY/DKK JPY/DKK USD/DKK CAD/DKK GBP/DKK
1 Reported operating profit is now expected to be negatively impacted by 4 percentage points compared with the expected positive impact of 1 percentage point as guided in connection with the report for the first three months of 2017. The change reflects the significant depreciation of the US dollar and other key invoicing currencies versus the Euro and the Danish krone.
2 DKK per 100; 3 As of 4 August 2016 and 2017, respectively; 4 Operating profit in DKK million per annum; 5 Chinese Yuan traded offshore (CNH)
Hedged Currencies2
2016 average3
2017 average3
Spot rate Q1 (28 Apr)
Spot rate Q2 (4 Aug)
Change
USD 673 680 680 626 (8%)
CNY 101.3 99.2 98.6 93.2 (5%)
JPY 6.21 6.05 6.10 5.69 (7%)
GBP 911 860 880 823 (6%)
CAD 508 514 499 498 (0%)
Hedged Currencies2
Impact of a 5% move4
Hedging (months)
USD 1,900 12
CNY 305 65
JPY 185 12
GBP 85 13
CAD 80 11
620
640
660
680
700
720
3 1 2 4
2016 2017
1 2
Yearly average USD/DKK Quarterly average
Exchange r
ate
U
SD
vs. D
KK
(8%) from 28 Apr to 4 Aug
Slide 16
5,05
4,10
3,50
4,72
11,82 11,82
Financial outlook for 2017
The financial outlook is based on an assumption of a continuation of the current business environment and given the current scope of business activities and has been prepared assuming that currency exchange rates remain at the level as of 4 August 2017
Investor presentation First six months of 2017
Sales growth - local currencies
Sales growth - reported
Operating profit growth - local currencies
Operating profit growth - reported
Financial items (net)
Effective tax rate
Capital expenditure
Free cash flow
Depreciation, amortisation and impairment losses
Expectations 9 August 2017
Previous expectations 3 May 2017
0% to 3%
Around 1 percentage points higher
-1% to 3%
Loss of around DKK 1.8 billion
21-23%
Around DKK 10 billion
Around DKK 3 billion
Around DKK 29-33 billion
Around 1 percentage points higher
1% to 3%
Around 3 percentage points lower
1% to 5%
Around 4 percentage points lower
Loss of around DKK 0.2 billion
21-22%
Around DKK 9.5 billion
Around DKK 3 billion
Around DKK 29-33 billion
Slide 17
5,05
4,10
3,50
4,72
11,82 11,82
Source: IMS MAT May 2017 volume and value (DKK) figures
Solid leadership positions and continued market opportunities Promising pipeline and product launches
Closing remarks
Investor presentation First six months of 2017
> > • The only company with a full portfolio of novel
insulin and GLP-1 products
• Semaglutide portfolio offers expansion opportunity with both injectable and oral administration
• Xultophy® supports promising outlook for insulin and GLP-1 combination therapy
• Saxenda® and multiple clinical stage development projects hold potential within obesity
• Broad pipeline within haemophilia
27% Novo Nordisk value market share in diabetes care and solid leadership position
~5% insulin market volume growth
44% Novo Nordisk insulin volume market share with leadership position across all regions
>20% GLP-1 volume market growth
55% Novo Nordisk GLP-1 volume market share with strong global leadership position
19 countries successfully launched Saxenda®
Slide 18
5,05
4,10
3,50
4,72
11,82 11,82
Share information Investor Relations contacts
Investor contact information
Investor presentation First six months of 2017
Novo Nordisk’s B shares are listed on the stock exchange in Copenhagen under the symbol ‘NOVO B’. Its ADRs are listed on the New York Stock Exchange under the symbol ‘NVO’. For further company information, visit Novo Nordisk on the internet at: novonordisk.com
Peter Hugreffe Ankersen +45 3075 9085 [email protected]
Hanna Ögren +45 3079 8519 [email protected]
Anders Mikkelsen +45 3079 4461 [email protected]
Christina Jensen +45 3079 3009 [email protected]
In North America:
Kasper Veje +1 609 235 8567 [email protected]
Novo Nordisk A/S Investor Relations Novo Allé, DK-2880 Bagsværd
Upcoming events
01 Nov 2017 Financial statement for the first nine months of 2017
01 Feb 2018 Financial statement for 2017
Slide 19
5,05
4,10
3,50
4,72
11,82 11,82
Appendix
Investor presentation First six months of 2017
1. Novo Nordisk at a glance
3. Biopharmaceuticals
4. Financials
2. Diabetes and obesity
5. Sustainability
Slide 20
5,05
4,10
3,50
4,72
11,82 11,82
Global leader in diabetes care Global insulin market leadership
Novo Nordisk at a glance
Source: IMS MAT May 2017 volume figures
Investor presentation First six months of 2017
R&D facility Manufacturing Global/regional headquarter
North America Operations: Market share 37%
Region Japan & Korea: Market share 49%
Region Europe: Market share 45%
Region China: Market share 53%
Global insulin market share: 46% • A focused pharmaceutical company with leading positions
in diabetes, haemophilia and growth hormone
• Significant growth opportunities driven by the diabetes
pandemic, fuelled by global presence and strong research
and development pipeline
• High barriers to entry in biologics
• Operating profit growth targeting 5% on average
• Earnings conversion to cash targeting 90%
• Cash generated returned to shareholders
Region AAMEO: Market share 57%
AAMEO: Africa, Asia, Middle East & Oceania
Region Latin America: Market share 42%
Slide 21
5,05
4,10
3,50
4,72
11,82 11,82
Our strategic foundation remains solid and our core purpose unchanged
STRATEGIC PRIORITIES
Expand leadership in DIABETES
Pursue leadership in OBESITY
Expand leadership in GROWTH DISORDERS
Pursue leadership in HAEMOPHILIA
Strengthen leadership in GROWTH DISORDERS
Strengthen leadership in OBESITY CARE
Strengthen leadership in DIABETES CARE
Pursue leadership in HAEMOPHILIA
Expand into other SERIOUS CHRONIC DISEASES
Novo Nordisk Way
Engineering, formulating, developing and delivering protein-based treatments
Deep disease understanding
Efficient large-scale production of proteins
Global commercial reach and leader in chronic disease care
Driving change to defeat diabetes and other serious chronic conditions
CORE CAPABILITIES
Investor presentation First six months of 2017
Slide 22
5,05
4,10
3,50
4,72
11,82 11,82
0%
10%
20%
30%
40%
50%
0
5
10
15
20
25
Novo Nordisk has leading positions in diabetes, haemophilia and growth disorders
Investor presentation First six months of 2017
DKK billion
1 CAGR for 5-year period Source: IMS MAT May, 2017 value figures
Growth disorders Diabetes
DKK billion Novo Nordisk value market share
Global market position
Market value
1 CAGR for 5-year period Source: IMS MAT May, 2017 value figures
0%
10%
20%
30%
40%
50%
0
100
200
300
400
500#1 #1
CAGR1 value: 17.6% CAGR1 value: 2.2%
May 2012
May 2017
May 2012
May 2017
Market value
0%
10%
20%
30%
40%
50%
0
10
20
30
40
50
60
70
DKK billion
Haemophilia Market value
Note: Annual sales figures for Haemophilia A, B and inhibitor segment 1 CAGR for 5-year period Source: Company reports
#2
CAGR1 value: 1.7%
FY 2012
FY 2016
Novo Nordisk value market share
Global market position
Novo Nordisk value market share
Global market position
Slide 23
5,05
4,10
3,50
4,72
11,82 11,82
0
100
200
300
400
500
600
700
International Diabetes Federation projects that 642 million people will have diabetes by 2040
0
5
10
15
20
25
30
35
Novo Nordisk reported quarterly sales by therapy
Reg: Region; J&K: Japan & Korea; AAMEO: Africa, Asia, Middle-East and Oceania; LATAM: Latin America Note: 20-79 age group 1 CAGR for 15-year period Source: International Diabetes Federation: Diabetes Atlas 1st and 7th Edition, 2000 and 2015
Top line growth driven by the diabetes pandemic
1 CAGR for 10-year period 2 Haemophilia includes NovoSeven®, NovoThirteen® (as of Q1 2013) and NovoEight® (as of Q1 2014)
Investor presentation First six months of 2017
DKK billion
Diabetes and obesity Haemophilia2
Norditropin® Other
Reported sales CAGR1: 10.5%
6.3%
6.3%
12.0%
-1.9%
Q2 2007
Q2 2017
Million people
2000 2015 2040E
151
415
CAGR1: 7.0%
642
Reg China
Reg Europe North America Reg AAMEO
Reg J&K Reg LATAM
Slide 24
5,05
4,10
3,50
4,72
11,82 11,82
0%
10%
20%
30%
0
50
100
150
200
250
300
350
400
450
500
1 CAGR for 10-year period OAD: Oral Anti-diabetic Source: IMS Monthly MAT May, 2017 value figures
Global diabetes care market by treatment class
Global diabetes care value market share
Novo Nordisk has a strong leadership position within the growing diabetes care market
Source: IMS Monthly MAT May, 2017 value figures
Investor presentation First six months of 2017
May 2007
May 2017
27%
GSK
Merck Eli Lilly Sanofi
Takeda
Novo Nordisk
AstraZeneca Novartis DKK billion
OAD Insulin GLP-1
Total market: CAGR1 15.3%
CAGR1 17.9%
Injectables: CAGR1 19.5%
CAGR1 10.8%
May 2007
May 2017
CAGR1 33.9%
Slide 25
5,05
4,10
3,50
4,72
11,82 11,82
NovoEight®
NovoSeven®
NovoThirteen®
Norditropin®
Significant growth opportunities fuelled by strong pipeline across all four strategic focus areas
1 Approved in all triad markets (US, EU and Japan), unless noted 2 Study conducted in adult growth hormone disorder 3 REBIYNIN® is the brand name in the US and Refixia® in the EU GG: Glucagon GLP-1
Investor presentation First six months of 2017
Saxenda®
Semaglutide – QW GLP-1
Fast-acting insulin aspart (US) Oral GLP-1
PHASE 1 PHASE 2 PHASE 3 APPROVED1
NovoRapid®
NovoMix®
Victoza®
Levemir®
Somapacitan – QW GH2
N8-GP – Long-acting rFVIII
Tresiba®
Ryzodeg®
Diabetes Obesity & other Haemophilia Growth disorders
Xultophy®
SUBMITTED
Semaglutide – QD GLP-1
Semaglutide NASH
Anti-IL-21 and liraglutide
LAI287 – QW basal insulin
NN7415 – Concizumab
G530S – Glucagon analogue
NN9838 – Amylin analogue
NN9747 – PYY analogue
NN1406 – Mealtime insulin
NN9277 – GG-co-agonist
Fiasp® (EU)
NN9499 – FGF21 obesity
NN7170 – Sc N8-GP
NN9423 – Tri-agonist 1706
Semaglutide – QD GLP-1
REBINYN®/Refixia®3
Slide 26
5,05
4,10
3,50
4,72
11,82 11,82
FTEs in sales regions1
Growth opportunities supported by strong global presence in both sales and manufacturing
1 FTEs represent full-time equivalents in Novo Nordisk’s sales regions (excludes all other employees in headquarter, research sites and manufacturing sites) as of May 2017 2 New Hampshire facility is currently under establishment
Investor presentation First six months of 2017
Region Japan & Korea: ~1,200
Region China: ~3,000
Region Africa, Asia, Middle-East and Oceania (AAMEO):
North America Operations: ~4,800
Region Europe: ~2,700
Total non-HQ/manufacturing FTEs: ~17,0001
West Lebanon, NH, USA (~170 FTEs)2
Biopharmaceutical API production
• Diabetes API production • Filling • Assembly • Packaging of above
Clayton, NC, USA (~800 FTEs)
Montes Claros, Brazil (~920 FTEs)
• Filling • Assembly • Packaging
Denmark (~9,500 FTEs)
• Filling • Assembly • Packaging
Chartres, France (~1,100 FTEs)
• Filling • Assembly • Packaging
Kaluga, Russia (~250 FTEs)
• Packaging
• Filling • Moulding and Assembly • Packaging
Tianjin, China (~1,000 FTEs)
Koriyama, Japan (~70 FTEs)
• Diabetes and biopharmaceutical API production
• Filling • Moulding and assembly • Packaging
Global manufacturing setup
Region Latin America: ~850
~4,500
Slide 27
5,05
4,10
3,50
4,72
11,82 11,82
Novo Nordisk’s position is protected by patents and value chain setup Barriers to entry for biosimilar players
Solid patent protection of innovative drugs
1 List does not include all marketed Novo Nordisk products. 2 Formulation patent expiration year 3 Protected by patents on the individual compounds insulin degludec and liraglutide as listed. 4 Assuming paediatric extension. 5 Saxenda patent identical to the Victoza® patent. Exp: Expired. Source: Novo Nordisk
PK: Pharmacokinetic, PD: Pharmacodynamic; CAPEX: Capital expenditure
Investor presentation First six months of 2017
Research & Development
Manufacturing
Commercialisation
Unique value chain position Patent protection1
EU/US0
• History of protein engineering
• Highly efficient, flexible and capital intensive manufacturing
• Global commercial footprint
• Need to show comparability in PK/PD trials
• Strict regulatory requirements in EU and the US
• Requirement for both drug and device offering
Research & Development
• Economies of scale for incumbents
• Up-front CAPEX requirements with slow return on investment
Manufacturing
Commercialisation
• Large and fragmented target audience
• Cost pressure from payers
• On-going conversion to next generation drugs and slow market dynamics
2018/192
exp 2015/1722
20172/172
20234/2352
exp 2017/172
2028/292
2028/292
202932
203022
Slide 28
5,05
4,10
3,50
4,72
11,82 11,82
Diabetes and obesity
Investor presentation First six months of 2017
Slide 29
5,05
4,10
3,50
4,72
11,82 11,82
Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces
Primary classifications:
Type 1 diabetes: Complete insulin deficiency due to destruction of beta-cells in the pancreas
Type 2 diabetes: Characterised by some degree of insulin resistance and insulin deficiency
Insulin:
• Facilitates uptake of blood sugar into cells
• Inhibits glucose release from the liver
Facts about diabetes The aim of insulin therapy is to recreate normal
blood insulin profile
Investor presentation First six months of 2017
Liver Pancreas
Muscle
Fat cell
6:00
0
10
20
30
40
50
60
70
10:00 14:00 18:00
Insulin (
µ U
/ m
L )
22:00 2:00 6:00
Short-lived, rapidly generated meal-related peaks (prandial)
Sustained Insulin profile (basal)
Time of day
Breakfast Lunch Dinner
Diabetes – the inability to manage blood sugar levels appropriately
Slide 30
5,05
4,10
3,50
4,72
11,82 11,82
<4.5% 4.5-5.9% 6.0-7.4% 7.5-8.9% 9.0-10.4% ≥10.5%
US CDC data on obesity and diabetes prevalence among adults
CDC: Centers for Disease Control and Prevention Source: CDC’s Division of Diabetes Translation. National Diabetes Surveillance System available at http://www.cdc.gov/diabetes
Diabetes pandemic is fuelled by growing rates of obesity
Investor presentation First six months of 2017
Obesity prevalence (BMI ≥30 kg/m2)
Diabetes prevalence
1994 2000 2014
<14.0% 14.0-17.9% 18.0-21.9% 22.0-25.9% 26.0-29.9% ≥30%
Slide 31
5,05
4,10
3,50
4,72
11,82 11,82
Diagnosis and optimal treatment remains a challenge – the rule of halves
The worldwide challenge of glycaemic control: Mean HbA1C in type 2 diabetes
Poor diagnosis rates, lack of access to optimal treatment and poor glycaemic control remain global problems
1 Harris et al. Diabetes Res Clin Pract 2005;70:90–7; 2 Hoerger et.al. Diabetes Care 2008;31:81–6; 3 Lopez Stewart et al. Rev Panam Salud Publica 2007;22:12–20; 4 Valensi et al. Int J Clin Pract 2009;63(3):522-31; 5 Arai et al. J Diabetes Investig. 2012 Aug 20;3(4):396-401; 6 Ko et al. Diab Med 2007;24:55–62; 7 Oguz et al. Curr Med Res Opin 2013;29:911–20; 8 Liebl et al. Diab Ther 2012;3:e1–10; 9 Blak et al. Diab Med 2012;29:e13-20
Investor presentation First six months of 2017
50% reach target 50% reach target
All people with diabetes
50% are diagnosed
50% have access to care
50% get decent care
100%
50%
25%
12%
Canada 7.3%1
US 7.2%2
Latin America 7.6%3
China 7.2-9.5%4
India 7.3-9.3%4
Japan 7.3–7.7%5
Korea 7.9–8.7%6
Russia 7.2-9.5%4
Germany 6.7-9.2%7
Greece 7.1–9.7%7,8,4
Italy 7.7-8.3%4
Poland 7.3-8.9%4
Portugal 7.9-9.7%7
Romania 7.9-9.9%7
Spain 7.6-9.2%8
Sweden 7.4-8.7%7
Turkey 7.6-10.6%7
UK 7.4-8.7%9
Slide 32
5,05
4,10
3,50
4,72
11,82 11,82
Risk reduction by lowering HbA1c by 1%-point UK Prospective Diabetes Study 10 year follow-up:
Legacy effect of tight glycaemic control
UKPDS: Tight glycaemic control reduces risk of micro- and macrovascular complications
UKPDS: UK Prospective Diabetes Study Source: UKPDS, Stratton et al. BMJ 2000; vol. 321:405–12
Source: NEJM, vol. 359, Oct 2008
Investor presentation First six months of 2017
In
cid
en
ce r
isk (
%)
–21%*
–14%
–37%*
–43%* *p<0.0001 –50
–40
–30
–20
–10
0
Diabetes-related death
Myocardial infarction
Microvascular complications
Peripheral vascular disease
Relative risk reduction of intensive vs. conventional treatment (%)
25 24 Microvascular disease
16 15 Myocardial infarction
6 13 All-cause mortality
SU/Insulin 1997 2007
10 17 Diabetes-related death
SU/Insulin treated patients
Statistically significant improvement
Slide 33
5,05
4,10
3,50
4,72
11,82 11,82
Progression of type 2 diabetes and treatment intensification
Distribution of patients and value across treatment classes
Insulin is the ultimate care for people with diabetes
OAD: Oral anti-diabetic Note: Patient distribution across treatment classes is indicative and based on data for US, UK, Germany and France. Value figures based on IMS MAT May 2017 Source: IMS PharMetrix claims data, IMS disease analyser, IMS Midas
Investor presentation First six months of 2017
-c
ell f
un
cti
on
Time
Diet and exercise
OAD
GLP-1
Insulin
OAD GLP-1 Insulin
Patients Value
28%
54%
9% 68%
37%
0%
20%
40%
60%
80%
100%
4%
Slide 34
5,05
4,10
3,50
4,72
11,82 11,82
0
50
100
150
200
250
300
350
400
450
500
Insulin action profiles Global insulin volume market by segment
The insulin market is comprised of three segments
1 CAGR for 5-year period. Value in DKK Source: IMS Monthly MAT volume and value May 2017 (DKK) figures
Investor presentation First six months of 2017
Time of day
6:00 10:00 14:00 18:00 22:00 2:00 6:00
Breakfast Lunch Dinner
Long-acting
Premix
Fast-acting
CAGR volume1: 4.5% CAGR value1: 19.4%
34%
29%
37%
40%
26%
34%
May 2012
Long-acting
Premix
Fast-acting
tMU
May 2017
Slide 35
5,05
4,10
3,50
4,72
11,82 11,82
Commonly prescribed product classes for the treatment of type 2 diabetes
Class HbA1C
change Hypoglycae-
mia risk
Weight
change CVD risk
Dosing
(pr. day)
Contraindication/ undesired effects
Metformin 1.5 No Neutral Minimal 2 OADs Kidney, liver
Sulfonylurea 1.5 Yes Gain None 1 OAD Essentially none
TZDs 0.5 - 1.4 No Gain Varies 1 OAD CHF, liver
DPP-IV inhibitors 0.6 - 0.8 No Neutral TBD 1-2 OAD None
SGLT-2 inhibitors 0.5 - 0.9 No Loss Varies 1 OAD Genital infections, urinary
tract infections
GLP-1 1.0 - 2.0 No Loss Varies Varies GI side effects, MTC
Long-acting insulin 1.5 - 2.5 Yes Gain TG and HDL 1 injection Hypoglycaemia
Fast-acting insulin 1.5 - 2.5 Yes Gain TG and HDL 1-4 injections Hypoglycaemia
Note: TG and HDL: Beneficial effect on triglycerides and high-density lipoprotein cholesterol; CHF: Congestive heart failure; GI: Gastro intestinal; MTC: Medullary thyroid cancer; TZD: thiazolidinediones; OAD: Oral anti-diabetic; TBD: to be defined. Sources: Adapted from: Nathan DM, et al. Diabetes Care. 2006; 29:1963-1972; Nathan DM, et al. Diabetes Care. 2007;30:753-759; Nathan DM, et al. Diabetes Care. 2008;31:173-175. ADA. Diabetes Care. 2008;31:S12-S54. WelChol PI. 1/2008.
Medications used for the treatment of type 2 diabetes
Investor presentation First six months of 2017
Slide 36
5,05
4,10
3,50
4,72
11,82 11,82
AAMEO: Africa, Asia, Middle-East and Oceania
1 IMS only covers part of the channels in Region AAMEO and Region China Source: IMS May, 2017 Monthly MAT volume and value (DKK) figures
Solid position in the diabetes care market across all regions with leading insulin market share
Investor presentation First six months of 2017
Regions Insulin volume
market composition Insulin volume market share
North America
Region Europe
Region AAMEO1
Region China1
Region Japan & Korea
Novo Nordisk
Others Premix
Fast-acting
Long-acting
47% 53%
51% 49%
43% 57%
55% 45%
63% 37%
61% 17%
22%
39% 23%
38%
25% 49%
26%
41% 18%
41%
52% 10%
38%
Diabetes care value market composition
Diabetes care value market share
Novo Nordisk
Others
Insulin
OAD
69% 31%
89% 11%
76% 24%
72% 28%
71% 29%
52% 47%
1%
80% 17%
3%
54% 44%
2%
42% 48%
10%
30% 58%
12%
GLP-1
Region Latin America
58% 42% 77% 7%
16% 84% 16% 68%
27%
5%
Slide 37
5,05
4,10
3,50
4,72
11,82 11,82
0%
5%
10%
15%
20%
25%
30%
0%
20%
40%
60%
80%
100%
Regional insulin volume growth
Reg: Region; J&K: Japan & Korea; AAMEO: Africa, Asia, Middle-East and Oceania; LATAM: Latin America Note: Data is sensitive to changes in IMS data collection and reporting methodology Source: IMS Monthly MAT May, 2017 volume figures
Stable global insulin volume growth
Investor presentation First six months of 2017
May 2012
May 2017
May 2012
May 2017
33%
31%
Reg: Region; J&K: Japan & Korea; AAMEO: Africa, Asia, Middle-East and Oceania; LATAM: Latin America Note: Data is sensitive to changes in IMS data collection and reporting methodology Source: IMS Monthly MAT May, 2017 volume figures
Regional insulin volume market split
World
North America Reg AAMEO Reg China
Reg J&K
Reg Europe
Reg LATAM Reg China
Reg Europe North America Reg AAMEO Reg J&K
Reg LATAM
3%
21%
9%
3%
4%
Slide 38
5,05
4,10
3,50
4,72
11,82 11,82
0%
20%
40%
60%
80%
100%
0
100
200
300
400
500
Th
ou
san
ds
0%
20%
40%
60%
80%
100%
0
100
200
300
400
500
Thousands
0%
20%
40%
60%
80%
100%
0
100
200
300
400
500
Thousands
Novo Nordisk global volume market share across insulin classes
1 Includes animal insulin. 2 Annual value of total insulin class. 3 MI: Modern insulin.; NGI: New-generation insulin; tMU: Thousand mega units Note: Data is sensitive to changes in IMS data collection and reporting methodology Source: IMS, Monthly MAT May, 2017 value and volume figures
Maintaining global insulin leadership by sustaining modern and new-generation insulin market share
Investor presentation First six months of 2017
May 2012
May 2017
May 2012
May 2017
May 2012
May 2017
Novo Nordisk class MS (%) class volume
Human insulin1
Market value2: DKK 25 billion
MI and NGI3
Market value2: DKK 225 billion
Total insulin
Market value2: DKK 250 billion
tMU tMU tMU
Slide 39
5,05
4,10
3,50
4,72
11,82 11,82
0%
10%
20%
30%
40%
50%
60%
Global insulin market Global modern and new-generation insulin
volume market shares
Strong underlying insulin market growth and sustained global volume market share
1 MI: Modern insulin. NGI: New-generation insulin 2 CAGR for 5-year period Note: Data is sensitive to changes in IMS data collection and reporting methodology Source: IMS Monthly MAT May, 2017 volume and value (DKK) figures
Note: Data is sensitive to changes in IMS data collection and reporting methodology, does not add up to 100% due to other manufacturers Source: IMS Monthly MAT May, 2017 volume figures
Investor presentation First six months of 2017
May 2017
May 2012
May 2017
Eli Lilly Novo Nordisk Sanofi
0%
20%
40%
60%
80%
100%
0
100
200
300
400
500
MI and NGI1
Human insulin
tMU Penetration Device penetration Modern insulin penetration1
CAGR volume2: 4.5% CAGR value2: 19.4%
44%
35%
19%
May 2012
Slide 40
5,05
4,10
3,50
4,72
11,82 11,82
0%
20%
40%
60%
80%
100%
0
40
80
120
160
200
0%
20%
40%
60%
80%
100%
0
40
80
120
160
200
Continued global single digit volume growth within the modern insulin segments
1 CAGR for 5-year period. 2 Includes new-generation Insulin. tMU: Thousand mega units Note: Modern insulin (MI) penetration is of total segment, ie including animal and human insulin; Data is sensitive to changes in IMS data collection and reporting methodology Source: IMS Monthly MAT May, 2017 volume figures
Investor presentation First six months of 2017
Fast-acting insulin Long-acting insulin
tMU
Levemir® share Segment volume NovoRapid® market share Segment volume
NovoMix® market share Segment volume
tMU tMU
0%
20%
40%
60%
80%
100%
0
40
80
120
160
200
May 2012
May 2017
May 2012
May 2017
May 2012
May 2017
Premix insulin
CAGR1 volume: 6.0% MI penetration2: 70.8%
CAGR1 volume: 5.1% MI penetration: 78.1%
CAGR1 volume: 1.9% MI penetration: 46.4%
Tresiba® share
Slide 41
5,05
4,10
3,50
4,72
11,82 11,82
0%
20%
40%
60%
80%
100%
0
20
40
60
80
100
120
140
160
0%
10%
20%
30%
40%
50%
60%
Insulin market by segments in the US MI and NGI volume market shares in the US
Solid US market share within the modern and new-generation insulin segment
1 CAGR for 5-year period Source: IMS Monthly MAT May, 2017 volume and value (DKK) figures
Source: IMS Monthly MAT May, 2017 volume figures
Investor presentation First six months of 2017
Modern Insulin penetration Device penetration
May 2012
May 2017
May 2012
May 2017
Eli Lilly Novo Nordisk Sanofi tMU Penetration CAGR volume1: 2.6%
CAGR value1: 26.3%
38%
39%
23%
Fast-acting
Long-acting
Premix
Slide 42
5,05
4,10
3,50
4,72
11,82 11,82
Tresiba® share
0%
20%
40%
60%
80%
100%
0
10
20
30
40
50
60
70
80
0%
20%
40%
60%
80%
100%
0
10
20
30
40
50
60
70
80
Novo Nordisk’s modern insulins maintain market share in the US insulin market
1 CAGR for 5-year period; tMU: Thousand mega units Note: US trend data reflect changes to IMS data collection coverage and methodology as of January 2012. Modern insulin (MI) penetration is of total segment, ie including human insulin Source: IMS Monthly MAT May, 2017 volume figures
Investor presentation First six months of 2017
US long-acting insulin
tMU
Levemir® share Segment volume
CAGR volume1: 4.3% MI penetration: 77.9%
May 2012
May 2017
0%
20%
40%
60%
80%
100%
-
10
20
30
40
50
60
70
80
0
US fast-acting insulin
NovoLog® share Segment volume
NovoLog® Mix 70/30 share Segment volume
tMU tMU
US premix insulin
CAGR volume1: 3.4% MI penetration: 83.9%
CAGR volume1: (6.1%) MI penetration: 52.4%
May 2012
May 2017
May 2017
May 2012
Slide 43
5,05
4,10
3,50
4,72
11,82 11,82
All other PBMs
32%
26%
24%
8%
3% 2%
4%
47% 44%
17% 18%
22% 22%
8% 8%
0%
20%
40%
60%
80%
100%
US population by health insurance status expected to remain stable in coming years
In 2016 PBMs covered 266 million lives and the market has consolidated
US health insurance is dominated by few large commercial payers with slow expansion of public insurance coverage
1 2016 data reflect historical data in Jan 2016 2 Managed care population was slightly underestimated as only population under age 65 were captured to avoid double counting with those eligible for Medicare. Source: Congressional Budget Office Health Insurance Coverage 2016-2026; Medicare Enrollment Dashboard; CMS Health Insurance Enrollment Projection 2015-2025; Medicaid and CHIP Enrollment Report Jan. 2016
Investor presentation First six months of 2017
PBM: Pharmacy Benefit Manager Note: Covers all main channels (Managed Care, Medicare Part D and Medicaid); market share based on claim adjudication coverage, i.e. not on formulary/rebate decision power Source: Cleveland Research PBM Intelligence 2016
Express Scripts
CVS Health
United Healthcare Group (OptumRx)
& Catamaran
Prime
Humana
MedImpact
324 333 US population (million)
Managed care2 Medicare Medicaid Uninsured Public exchanges Other
20161 2020
Slide 44
5,05
4,10
3,50
4,72
11,82 11,82
0%
10%
20%
30%
40%
50%
60%
0%
20%
40%
60%
80%
100%
0
20
40
60
80
100
120
140
160
180
European MI and NGI volume market shares
Maintained leadership position in the European modern and new-generation insulin market
Investor presentation First six months of 2017
1 CAGR for 5-year period 2 MI: Modern insulin; NGI: New-generation insulin Source: IMS Monthly MAT May, 2017 volume and value (DKK) figures
MI and NGI penetration Device penetration
May 2012
May 2017
Eli Lilly Novo Nordisk Sanofi
Fast-acting
Long-acting
tMU Penetration
Premix
44%
36%
19%
MI: Modern insulin; NGI: New-generation insulin Source: IMS Monthly MAT May, 2017 volume figures, numbers do not add up to 100% due to smaller insulin manufacturers
CAGR volume1: 2.2% CAGR value1: 2.7%
May 2017
May 2012
European insulin market by segments
Slide 45
5,05
4,10
3,50
4,72
11,82 11,82
0%
10%
20%
30%
40%
50%
60%
70%
0%
20%
40%
60%
80%
100%
0
20
40
60
80
100
120
Region AAMEO insulin market by segments Region AAMEO MI and NGI volume market
shares
Stable leadership position in Africa, Asia, Middle-East and Oceania (Region AAMEO)
1 CAGR for 5-year period. Note: IMS only covers the following 8 markets in AAMEO (retail data): Algeria, Egypt, India, New Zealand, Russia, Saudi Arabia, South Africa & Turkey Source: IMS Monthly MAT May, 2017 volume and value (DKK) figures MI: Modern insulin; NGI: New-generation insulin
Source: IMS Monthly MAT May, 2017 volume figures, numbers do not add up to 100% due to smaller insulin manufacturers MI: Modern insulin; NGI: New-generation insulin
Investor presentation First six months of 2017
Device penetration
tMU Penetration CAGR volume1: 8.9% CAGR value1: 6.8%
Biocon
57%
14%
20%
May 2012
3%
Sanofi Novo Nordisk
Fast-acting
Long-acting
Premix
May 2017
Eli Lilly MI and NGI penetration
May 2017
May 2012
Slide 46
5,05
4,10
3,50
4,72
11,82 11,82
0%
10%
20%
30%
40%
50%
60%
70%
0%
20%
40%
60%
80%
100%
0
2
4
6
8
10
12
14
16
Japan & Korea insulin market by segments Japan & Korea MI and NGI volume shares
Solid market leadership position in Japan & Korea
1 CAGR for 5-year period MI: Modern insulin; NGI: New-generation insulin Source: IMS Monthly MAT May, 2017 volume and value (DKK) figures
Source: IMS Monthly MAT May, 2017 volume figures MI: Modern insulin; NGI: New-generation insulin
Investor presentation First six months of 2017
Device penetration Eli Lilly Novo Nordisk Sanofi
tMU Penetration CAGR volume1: 0.4% CAGR value1: (2.3%)
Fast-acting
Long-acting
Premix
48%
26%
26%
May 2012
May 2017
MI and NGI penetration
May 2017
May 2012
Slide 47
5,05
4,10
3,50
4,72
11,82 11,82
0%
20%
40%
60%
80%
0%
10%
20%
30%
40%
50%
60%
70%
14%
Japanese basal value market shares Japanese total insulin value market shares
Solid Tresiba® performance strengthens basal insulin market share in Japan
Source: IMS Monthly May, 2017 value figures Source: IMS Monthly May, 2017 value figures
Investor presentation First six months of 2017
Eli Lilly Novo Nordisk Sanofi
May 2014
May 2017
58%
23%
18%
May 2014
May 2017
glargine U100
NN Total Basal Tresiba® Levemir® NPH
biosimilar glargine
50%
22%
41%
7% 3%
Glargine U300
12%
Slide 48
5,05
4,10
3,50
4,72
11,82 11,82
0%
10%
20%
30%
40%
50%
60%
70%
0%
20%
40%
60%
80%
100%
0
5
10
15
20
25
30
35
40
45
Chinese insulin market by segments Chinese insulin volume market shares
Solid growth in the Chinese insulin market
1 CAGR for 5-year period Note: IMS covers around 50% of the total Chinese market (hospital data) Source: IMS Monthly MAT May, 2017 volume and value (DKK) figures
Note: Only selected competitors shown Source: IMS Monthly MAT May, 2017 volume figures, numbers do not add up to 100% due to smaller insulin manufacturers not included
Investor presentation First six months of 2017
Modern Insulin penetration Device penetration
tMU Penetration CAGR volume1: 12.1% CAGR value1: 18.5%
Fast-acting
Long-acting
Premix
Eli Lilly Novo Nordisk
Sanofi
Tonghua Dongbao
53%
6%
13%
6%
10%
May 2012
May 2017
May 2017
May 2012
United Lab Gan & Lee
2%
Slide 49
5,05
4,10
3,50
4,72
11,82 11,82
0%
20%
40%
60%
80%
100%
0
2
4
6
8
0%
10%
20%
30%
40%
50%
60%
70%
Chinese insulin market by segments Chinese total insulin value market shares
Continued expansion of the modern insulin market in China
Investor presentation First six months of 2017
bDKK Eli Lilly Novo Nordisk Sanofi
Tonghua Dongbao
50%
17%
11% 6%
May 2012
May 2017
May 2017
May 2012
United Lab Gan & Lee
Modern Insulin penetration Device penetration
1%
1 CAGR for 5-year period Note: IMS covers around 50% of the total Chinese market (hospital data) Source: IMS Rolling MAT May, 2017 value (DKK) figures
Note: Only selected competitors Source: IMS Rolling MAT May, 2017 value figures, numbers do not add up to 100% due to smaller insulin manufacturers not included
Penetration
Fast-acting
Long-acting
Premix
CAGR value1: 18.5%
11%
Slide 50
5,05
4,10
3,50
4,72
11,82 11,82
0%
10%
20%
30%
40%
50%
60%
70%
0%
20%
40%
60%
0
3
6
9
12
15
Latin America insulin market by segments Latin America MI and NGI volume shares
Strengthened insulin volume market share in Latin America
1 CAGR for 5-year period Note: IMS only covers the following 4 markets in Latin America (retail data): Argentina, Brazil, Colombia, Mexico Source: IMS Monthly MAT May, 2017 volume and value (DKK) figures MI: Modern insulin; NGI: New-generation insulin
Note: Only top-3 shown Source: IMS Monthly MAT May, 2017 volume figures, numbers do not add up to 100% due to smaller insulin manufacturers not included MI: Modern insulin; NGI: New-generation insulin
Investor presentation First six months of 2017
MI and NGI penetration Device penetration tMU Penetration CAGR volume1: 13.4%
CAGR value1: 10.9%
Fast-acting
Long-acting
Premix
Novo Nordisk Eli Lilly Sanofi
42%
32%
15%
May 2012
May 2017
May 2017
May 2012
Slide 51
5,05
4,10
3,50
4,72
11,82 11,82
GLP-1 mechanism of action when blood sugar levels increase
GLP-1 lowers blood glucose in patients with type 2 diabetes
GLP-1 effect dependent on level of blood glucose − which reduces risk of hypoglycaemia compared to insulin
Source: Rachman et al. Diabetologia 1997;40:205–11
Investor presentation First six months of 2017
• Increases insulin secretion in the pancreas
• Reduces glucagon secretion in the liver
• Slows gastric emptying in the gut
• Creates sense of satiety in the brain
Glucose (mmol/L)
12
8
6
0
22.00 02.00 06.00 10.00 14.00
10
4
14
16
Time
2 Breakfast Lunch Snack
18.00
18
Type 2 diabetes patients, no GLP-1
Healthy controls receiving saline
Type 2 diabetes patients, with GLP-1
Pancreas
Liver
Brain
Gut
Slide 52
5,05
4,10
3,50
4,72
11,82 11,82
0%
5%
10%
15%
10%
2%
0%
2%
4%
6%
8%
10%
0
10
20
30
40
50
GLP-1 value in bDKK
Share of total diabetes care
market
GLP-1 value and patient share of the total diabetes market
The GLP-1 segment accounts for 11% of the total diabetes market value
Investor presentation First three months of 2017
GLP-1 value share of total diabetes
Global GLP-1 market Victoza®
dulaglutide exenatide other
GLP-1 patient share1 of total diabetes
Share of total diabetes care market
Reg: Region; AAMEO: Africa, Asia, Middle-East and Oceania; J&K: Japan & Korea; LATAM: Latin America. 1 Patient share is indicative and based on data for US, UK, Germany and France only. Source: Value data; IMS MAT May 2017. Patient data; IMS Disease Analyser (DE, FR, UK), IMS LRx & Pharmetrics (US) January 2017
Reg AAMEO
Reg J&K
Reg LATAM
Reg China
4%
World North America
Reg EU
1 CAGR for 5-year period Source: IMS Monthly MAT May, 2017 value figures (DKK)
CAGR value1: 35.6%
May 2012
May 2017
11%
13%
5% 4%
5%
1%
Slide 53
5,05
4,10
3,50
4,72
11,82 11,82
0%
10%
20%
30%
40%
50%
60%
70%
Region Europe
Regional GLP-1 volume growth
J&K: Japan & Korea; AAMEO: Africa, Asia, the Middle East and Oceania; LATAM: Latin America Note: Data is sensitive to changes in IMS data collection and reporting methodology Source: IMS Monthly MAT May, 2017 volume figures
Strong GLP-1 volume growth in all regions
Investor presentation First six months of 2017
0%
20%
40%
60%
80%
100%
May 2014
May 2017
May 2014
May 2017
7% 4% 0%
47%
J&K: Japan & Korea; AAMEO: Africa, Asia, the Middle East and Oceania; LATAM: Latin America Note: Data is sensitive to changes in IMS data collection and reporting methodology Source: IMS Monthly MAT May, 2017 volume figures
Regional GLP-1 volume market split
39%
3% Region China
Region Europe North America Region AAMEO
Region J&K Region LATAM World
North America
Region AAMEO
Region China
Region J&K Region LATAM
23%
Slide 54
5,05
4,10
3,50
4,72
11,82 11,82
0%
2%
4%
6%
8%
10%
12%
0
10
20
30
40
1 CAGR for 5-year period Source: IMS Monthly MAT May, 2017 value figures (DKK)
North America GLP-1 market
The GLP-1 segment accounts for 13% of the total diabetes care market in North America
Investor presentation First six months of 2017
May 2017
May 2012
CAGR value1: 41.7%
Key observations for Victoza® in the US market
• Victoza® value market share within the GLP-1 segment is 52%
• Around 81% of commercial and around 92% of Medicare Part D lives are covered without restrictions
• Around 63% of new patients are new to treatment or from OAD-only regimens
• Close to 71% of prescriptions are for the higher dose 1.8 mg (3-pen pack)1
GLP-1 value in bDKK
Share of total diabetes care
market
Victoza®
dulaglutide exenatide other
1 QIMS monthly, MAT May 2017
Slide 55
5,05
4,10
3,50
4,72
11,82 11,82
0%
20%
40%
60%
80%
100%
0%
2%
4%
6%
8%
10%
0
1
2
3
4
5
6
European GLP-1 market Victoza® value market share in Europe
The GLP-1 segment accounts for around 10% of the total diabetes care market in Europe
Investor presentation First six months of 2017
May 2017
May 2012
May 2012
May 2017
CAGR value1: 17.5%
1 CAGR for 5-year period Source: IMS Monthly MAT May, 2017 value figures (DKK)
Source: IMS Monthly MAT May, 2017 value figures (DKK)
62%
20% 15%
GLP-1 value market share
3%
GLP-1 value in bDKK
Share of total diabetes care
market
Victoza®
dulaglutide exenatide other Victoza®
dulaglutide exenatide other
Slide 56
5,05
4,10
3,50
4,72
11,82 11,82
0%
1%
2%
3%
0.0
0.1
0.2
0.3
0.4
0.5
0%
20%
40%
60%
80%
100%
Region AAMEO GLP-1 market Victoza® value market share in Region AAMEO
The GLP-1 segment accounts for more than 2% of the total diabetes care market in Region AAMEO
Investor presentation First six months of 2017
May 2017
May 2012
GLP-1 value market share
May 2012
May 2017
1 CAGR for 5-year period AAMEO: Africa, Asia, the Middle East and Oceania Source: IMS Monthly MAT May, 2017 value figures (DKK)
Source: IMS Monthly MAT May, 2017 value figures (DKK)
CAGR value1: 33.7%
51%
31%
18%
GLP-1 value in bDKK
Share of total diabetes care
market
Victoza®
dulaglutide exenatide lixisenatide Victoza®
dulaglutide exenatide lixisenatide
0%
Slide 57
5,05
4,10
3,50
4,72
11,82 11,82
0%
20%
40%
60%
80%
100%
0%
1%
2%
3%
0.0
0.2
0.4
0.6
0.8
1.0
1.2
Investor presentation First six months of 2017
May 2017
May 2012
May 2012
May 2017
1 CAGR for 5-year period Source: IMS Monthly MAT May, 2017 value figures (DKK)
Source: IMS Monthly MAT May, 2017 value figures (DKK)
CAGR value1: 20.4%
Japan & Korea GLP-1 market Victoza® value market share in Japan & Korea
The GLP-1 segment accounts for around 4% of the total diabetes care market in Japan & Korea
50%
9%
36%
5%
GLP-1 value market share
GLP-1 value in bDKK
Share of total diabetes care
market
Victoza®
dulaglutide exenatide other Victoza®
dulaglutide exenatide other
Slide 58
5,05
4,10
3,50
4,72
11,82 11,82
0%
20%
40%
60%
80%
100%
0%
1%
2%
3%
4%
5%
6%
7%
8%
0.0
0.1
0.2
0.3
0.4
0.5
0.6
Latin America GLP-1 market Victoza® value market share in Latin America
Strong market leadership of Victoza ® in Latin America
Investor presentation First six months of 2017
May 2017
May 2012
May 2012
May 2017
1 CAGR for 5-year period Source: IMS Monthly MAT May, 2017 value figures (DKK)
Source: IMS Monthly MAT May, 2017 value figures (DKK)
CAGR value1: 8.3% 83%
2% 14%
1%
GLP-1 value market share
GLP-1 value in bDKK
Share of total diabetes care
market
Victoza®
dulaglutide exenatide other Victoza®
dulaglutide exenatide other
Slide 59
5,05
4,10
3,50
4,72
11,82 11,82
0%
20%
40%
60%
80%
100%13% 12%
0%
20%
40%
60%
80%
100%
DPP-IV SGLT-2 Victoza® Other GLP-1
Share of segment value growth Segment value market shares
0
20
40
60
80
100
120
140
160
180
200
220
1 CAGR for 5-year period Note: Segment only includes DPP-IV, GLP-1 & SGLT-2. Other oral anti-diabetic agents and insulin excluded Source: IMS MAT May 2017 value figures
Victoza® maintains a 14% value market share in the GLP-1, SGLT-2 and DPP-IV segment
Investor presentation First six months of 2017
DKK billion
May 2012
May 2017
May 2012
May 2017
CAGR1 value: 29.5%
Victoza® 14%
2016 vs 2017
2015 vs 2016
Segment value
Slide 60
5,05
4,10
3,50
4,72
11,82 11,82
0%
20%
40%
60%
80%
0%
20%
40%
60%
80%
100%
Value market shares of key Novo Nordisk products in the US
% share of unrestricted market access of key Novo Nordisk products in the US
Value market share
Unrestricted Market access
Key Novo Nordisk diabetes care products remain broadly available in the US
Source: IMS NSP May 2017; Note: Market shares: NovoLog®: share of rapid acting insulin segment; Levemir®: share of basal insulin segment; Tresiba® share of basal insulin segment; Victoza®: share of GLP-1 segment
May 2014
May 2017
Apr 2014
Apr 2017
Source: FingerTip Formulary bridge/ April 2017 Nomenclature and Xponent PlanTrak using week-ending 5/5/2017; only considers bridged volume; excludes cash and mail order data; Note: Unrestricted access excludes prior authorisation, step edits and other restrictions Levemir® access based on FlexTouch® Pen; NovoLog® access based on FlexPen®; only considers bridged volume; Tresibe® launched in January 2016
Victoza® NovoLog® Levemir®
Tresiba®
Investor presentation First six months of 2017
Victoza® NovoLog® Levemir®
Tresiba®
Slide 61
5,05
4,10
3,50
4,72
11,82 11,82
Overview of current and future products in Novo Nordisk’s diabetes portfolio
1 Pending clinical development programmes and regulatory processes for oral semaglutide and semaglutide
Novo Nordisk current and future product portfolio covers the type 2 diabetes treatment flow1
Investor presentation First six months of 2017
When basal insulin is not enough
Once-daily optimisation
When metformin is not enough
When it's time for insulin
Mealtime insulin control
semaglutide
Actrapid® Mixtard® 30 Insulatard®
or
First generation analogues
Second generation analogues
Human insulin
or
oral semaglutide
Slide 62
5,05
4,10
3,50
4,72
11,82 11,82
R&D pipeline: Diabetes, obesity and other areas
1 Approved in EU on 10 Jan 2017
Investor presentation First six months of 2017
Product/project Type Indication Status (phase)
1 2 3 Filed Appr.
Fast-acting insulin aspart (NN1218)1 New formulation of insulin aspart Type 1+2
Semaglutide (NN9535) Once-weekly GLP-1 analogue Type 2
OG217SC (NN9924) Long-acting once-daily oral GLP-1 analogue Type 2
Semaglutide QD (NN9535) Once-daily GLP-1 analogue Type 2
Anti-IL-21 and liraglutide (NN9828) Immuno-metabolic combination of Anti-IL-21 and liraglutide Type 1
LAI287 (NN1436) Long-acting once-weekly basal insulin analogue Type 1+2
Mealtime insulin (NN1406) Liver-preferential mealtime insulin Type 1+2
PYY diabetes (NN9748) Peptide YY analogue Type 1+2
Semaglutide QD (NN9536) Once-daily GLP-1 analogue Obesity
G530S (NN9030) Glucagon analogue Obesity
AM833 (NN9838) Long-acting amylin analogue Obesity
GG-co-agonist (NN9277) Glucagon GLP-1 co-agonist Obesity
PYY obesity (NN9747) Peptide YY analogue Obesity
FGF21 Obesity (NN9499) Fibroblast growth factor 21 analogue Obesity
Tri-agonist 1706 (NN9423) Phase 1 trial initiated Obesity
Semaglutide NASH (NN9931) Long-acting once-daily GLP-1 analogue NASH
Slide 63
5,05
4,10
3,50
4,72
11,82 11,82
Key results and next step
Tresiba® demonstrated CV safety and reduced severe hypoglycaemia risk vs insulin glargine U100 in DEVOTE trial
Investor presentation First six months of 2017
• Non-inferiority on CV safety demonstrated with a hazard ratio of 0.91 in favour of Tresiba® relative to insulin glargine U100 with no statistically significant difference between the two treatments
• Compared to insulin glargine U100, Tresiba® demonstrated a superior and statistically significant:
• 27% reduction in the proportion of subjects with one or more severe hypoglycaemia episodes
• 40% reduction in the overall rate of severe hypoglycaemia episodes
• 53% reduction in the rate of nocturnal severe hypoglycaemia episodes
Next steps
• Awaiting regulatory decision by the end of Q1 2018 in the US and the EU
Non-inferiority of Tresiba® vs insulin glargine U100 was confirmed for time to first MACE
Patients with an event (%)
Months
Tresiba®
Hazard ratio = 0.91 95% CI (0.78;1.06)
P<0.001 for non-inferiority
0
2
4
6
8
10
12
0 5 10 15 20 25 30
CV: Cardiovascular, MACE: major adverse cardiovascular events Note: Patients 7,637. Key inclusion criteria: Adults above 50 years with type 2 diabetes and established cardiovascular disease, or above 60 years with multiple cardiovascular risk factors; HbA1c ≥7.0% or HbA1c <7.0% and current basal insulin therapy ≥20 units per day; treatment with ≥1 oral or injectable anti-diabetic drug(s). The trial was concluded after 681 events
Slide 64
5,05
4,10
3,50
4,72
11,82 11,82
Tresiba® shows lower rate of hypoglycaemia than insulin glargine U100 in SWITCH trials
Investor presentation First six months of 2017
2,463
429 92
2,201
277 69 0
500
1,000
1,500
2,000
2,500
3,000
Severe or BG
confirmed
symptomatic
events
Severe or BG
confirmed
symptomatic
nocturnal
events
Severe events
SWITCH 1 – type 1 diabetes SWITCH 2 – type 2 diabetes
Note: The prevalence of hypoglycaemia is measured during the maintenance period; Blood glucose confirmed hypoglycaemia is defined as <56 mg/dL (<3.1 mmol/L); The confirmatory secondary endpoint of proportions of subjects experiencing severe hypoglycaemia during the maintenance period did not reach statistical significance in the SWITCH 2 trial. * Statistically significant; BG: Blood glucose; PYE: Patient years exposed. Approved in EU. Reviewed with DEVOTE in US.
265
94
9
186
55 5 0
50
100
150
200
250
300
Severe or BGconfirmed
symptomaticevents
Severe or BGconfirmed
symptomaticnocturnal events
Severe events
-11%*
-36%*
-35%*
-30%*
-42%*
-46%
Tresiba® glargine U100 Hypoglycaemic events per 100 PYE
Hypoglycaemic events per 100 PYE
Slide 65
5,05
4,10
3,50
4,72
11,82 11,82
Regulatory decisions and next steps Fiasp® vs NovoRapid® EU label characteristics
Fast-acting insulin aspart approved in the EU and Canada, regulatory decision by FDA expected Q4 2017
PPG: Postprandial glucose; SC: Subcutaneous
Investor presentation First six months of 2017
• Fiasp® (fast-acting insulin aspart) launched in Germany, UK, Canada and Finland
• Next step: Launch roll-out in more European countries
• Class II resubmission of the NDA for fast-acting insulin aspart in the US on 29 March 2017
• Next step: Regulatory decision by the FDA expected in Q3 2017
NDA: New drug application
Efficacy
• Fiasp® HbA1c reduction of -0.32% compared NovoRapid® of -0.15% in type 1 diabetes patients
• Fiasp® 1-h PPG reduction of -0.29 mmol/l
Pharma-cokinetics
• Fiasp® twice as fast as NovoRapid®
• Twice as much insulin available during first 30 minutes with Fiasp®
Specific populations
• Fiasp® approved for pregnancy and pumps as NovoRapid®
• Paediatric use not yet approved for Fiasp® and more limited geriatric use vs NovoRapid®
Safety
• Overall safety of Fiasp® consistent with NovoRapid®
• Hypoglycaemia may occur earlier compared to other mealtime insulins
Slide 66
5,05
4,10
3,50
4,72
11,82 11,82
Victoza® statistically significantly reduced the risk of major adverse cardiovascular events in the LEADER trial
13% reduction in 3-point MACE with Victoza® compared with placebo
1 Inclusion criteria: Adults above 50 years with type 2 diabetes and established CV disease, above 60 years with multiple CV factors, HbA1C ≥ 7.0% MACE: major adverse cardiovascular events; 3-point MACE comprises cardiovascular death, non-fatal myocardial infarction and non-fatal stroke; CI: two-sided confidence interval
Key results
Patients1 with an event (%)
Time from randomisation (months)
Hazard ratio = 0.87 95% CI (0.78;0.97)
p<0.001 for non-inferiority p=0.011 for superiority
Victoza® Placebo • Superiority of Victoza® vs placebo was confirmed for time to first MACE in people with type 2 diabetes at high CV risk
• Victoza® reduced the MACE risk by 13%, driven by 22% reduction in CV mortality, 12% reduction in non-fatal myocardial infarctions and 11% reduction in non-fatal stroke, compared with placebo when added to standard of care
• Victoza® reduced all-cause mortality by 15% respectively, compared with placebo when added to standard of care
• The result was consistent across sensitivity analyses
• Victoza® appeared to have a safe and well tolerated profile, generally consistent with previous studies for Victoza®
0
5
10
15
20
0 6 12 18 24 30 36 42 48 54
Investor presentation First six months of 2017
Slide 67
5,05
4,10
3,50
4,72
11,82 11,82
Semaglutide demonstrated 26% reduction in composite CV outcome compared with placebo
Semaglutide significantly reduced the risk of major cardiovascular events with 26% vs placebo in SUSTAIN 6
Investor presentation First six months of 2017
Note: p-value is two-sided, pooled data reported for both semaglutide and placebo MACE: Major adverse cardiovascular event; 3-point MACE comprises cardiovascular death, non-fatal myocardial infarction and non-fatal stroke; CI: Confidence interval * No adjustment for multiple tests
Patients with an event (%)
Weeks
Hazard ratio = 0.74 (95% CI: 0.58;0.95) Events: 108 semaglutide; 146 placebo
p<0.001 for non-inferiority p=0.02 for superiority*
semaglutide
0
5
10
15
0 8 16 24 32 40 48 56 64 72 80 88 96 104
placebo
Key results and next step
• Non-inferiority of semaglutide compared to placebo was confirmed for time to first MACE in people with type 2 diabetes
• Semaglutide reduced the risk of MACE by 26% driven by reductions of non-fatal stroke by 39%* and non-fatal MI by 26%
• Semaglutide significantly reduced the risk of nephropathy while increasing the risk of retinopathy complications
• Next step: Novo Nordisk has submitted an NDA for semaglutide to regulatory authorities and expect regulatory feedback in Q4 2017
* P-value <0.001 NDA: New drug application
Slide 68
5,05
4,10
3,50
4,72
11,82 11,82
-1.6 -1.6 -1.5
-1.6
-1.8
-1.4 -1.5
-1.3
-0.9
-1.2
-1.4
-1.1
-0.5
-0.8
-2.0
-1.6
-1.2
-0.8
-0.4
0.00.0
-0.1 -0.4
Semaglutide demonstrated a statistically significant reduction in HbA1c vs comparators in the phase 3a trials
Comparison of HbA1c lowering effect in phase 3a SUSTAIN trials
*p < 0.001; QD: once-daily; QW: once-weekly; sema: semaglutide **SUSTAIN 1: semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes; SUSTAIN 5: semaglutide once-weekly versus placebo in subjects with type 2 diabetes added on to insulin; SUSTAIN 6: semaglutide once-weekly versus placebo, added-on to their standard-of-care treatment Source: SUSTAIN 1-5: Ahmann, et al, et al. Presented at the 77th Annual Scientific Sessions of the American Diabetes Association, San Diego, USA. Poster 1080-P; SUSTAIN 6 HbA1c: Marso SP, et al. N Engl J Med 2016;375:1834–44
Baseline SUSTAIN 1
8.1% SUSTAIN 3
8.3% SUSTAIN 4
8.2% SUSTAIN 2
8.1%
Ch
an
ge i
n H
bA
1c (
%)
*
SUSTAIN 5 8.4%
Investor presentation First six months of 2017
Sema 1 mg Sema 0.5 mg Exenatide QW Insulin glargine QD Sitagliptin 100 mg Placebo**
SUSTAIN 6 8.7%
*
* *
*
*
* *
*
* *
*
Slide 69
5,05
4,10
3,50
4,72
11,82 11,82
Semaglutide demonstrated a statistically significant reduction in weight vs comparators the the phase 3a trials
Comparison of weight reductions in phase 3a SUSTAIN trials
-4.5
-6.1 -5.6
-5.2
-6.4
-4.9
-3.7 -4.3
-1.9
-3.5 -3.7 -3.6
-1.0
-1.9
1.2
-1.4
-7.0
-6.0
-5.0
-4.0
-3.0
-2.0
-1.0
0.0
1.0
Baseline SUSTAIN 1
92kg SUSTAIN 3
96kg SUSTAIN 4
93kg SUSTAIN 2
89kg
Ch
an
ge i
n w
eig
ht
(kg
)
-6.1
*
SUSTAIN 5 92kg
Investor presentation First six months of 2017
Sema 1 mg Sema 0.5 mg Exenatide QW Insulin glargine QD Sitagliptin 100 mg Placebo**
SUSTAIN 6 92kg
* *
*
*
*
*
*
*
*
*
*
*p < 0.001; QD: once-daily; QW: once-weekly; sema: semaglutide **SUSTAIN 1: semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes; SUSTAIN 5: semaglutide once-weekly versus placebo in subjects with type 2 diabetes added on to insulin; SUSTAIN 6: semaglutide once-weekly versus placebo, added-on to their standard-of-care treatment Source: SUSTAIN 1-5: Lingvay, et al. Presented at the 77th Annual Scientific Sessions of the American Diabetes Association, San Diego, USA. Oral presentation 243-OR; SUSTAIN 6: Vilsbøll, et al. Presented at the 77th Annual Scientific Sessions of the American Diabetes Association, San Diego, USA. Poster 1125-P
-0.7
Slide 70
5,05
4,10
3,50
4,72
11,82 11,82
Investor presentation First six months of 2017
1 Inclusion criteria: Histological confirmation of NASH, BMI 25.0–45.0 kg/m2, NASH fibrosis stage 2 or 3, Histological NAFLD Activity Score ≥ 4 sc: subcutaneous; QD: Once-daily; NAFLD: non-alcoholic fatty liver disease; NASH: non-alcoholic steatohepatitis.
Once-daily semaglutide vs. placebo in patients with NASH trial design Phase 2 trial purpose and endpoints
Phase 2 trial with semaglutide for NASH initiated in November 2016
• Purpose: To compare the effects of semaglutide subcutanous once-daily versus placebo in achieving histologic resolution of NASH after 72 weeks
• Trial design: Randomised and double-blind
• Primary endpoint: NASH resolution without worsening in fibrosis after 72 weeks
• Secondary endpoint: At least one stage of improvement at week 72, change from baseline in NAFLD activity score, stage of fibrosis and biomarkers
• Results: Phase 2 trial results expected to be finalised in 2020
Semaglutide 0.4 mg sc QD
Semaglutide 0.2 mg sc QD
72 weeks
Placebo 0.1, 0.2 or 0.4 mg
Semaglutide 0.1 mg sc QD
Liver biopsy (recent or new)
Liver biopsy
372 patients1
Slide 71
5,05
4,10
3,50
4,72
11,82 11,82
Tresiba® label characteristics in triad markets
1 Observed in majority of the trials
Competitive Tresiba® label across all three triad markets
Investor presentation First six months of 2017
US Europe Japan
Efficacy
• Non-inferior HbA1c reduction
• Numerically greater FPG reduction
• Numerically lower insulin dose1
• Non-inferior HbA1c reduction
• Numerically greater FPG reduction
• Non-inferior HbA1c reduction
• Numerically greater FPG reduction
Profile • Half-life of 25 hours and duration of
action of at least 42 hours
• Day to day variability of 20%
• Duration of action beyond 42 hours • Four times lower day-to-day
variability vs insulin glargine
• Duration of action up to 26 hours in Japanese patients
• Four times lower day-to-day variability vs insulin glargine
Safety
• Overall safety consistent with insulin
• Lower rate of overall and nocturnal hypoglycaemia
• Overall safety consistent with insulin
• Lower rate of nocturnal hypoglycaemia in Asian subjects
Convenience • Injection any time of day
• Up to 80 and 160 units per injection
• Adjusting injection time when needed
• Up to 80 and 160 units per injection
• In case of missed dose take as soon as possible
• Overall safety consistent with insulin
• Hypoglycaemia rates for Tresiba®, but not comparator
Slide 72
5,05
4,10
3,50
4,72
11,82 11,82
Investor presentation First six months of 2017
US – Xultophy® 100/3.6 Europe - Xultophy®
Profile • A combination of insulin degludec and liraglutide • Administered as units: Each Xultophy® 100/3.6 dosage unit
contains 1 unit of insulin degludec and 0.036 mg of liraglutide
• Fixed combination product consisting of insulin degludec and liraglutide.
• Administered as dose steps: 1 dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide
Indication
• Adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily)
• Xultophy® is indicated for the treatment of adults with type 2 diabetes in combination with oral glucose-lowering agents
Convenience
• Once-daily administration at any time of the day, preferably at the same time of the day
• The pre-filled pen can provide from 1 up to 50 dose steps in one injection
• Once-daily administration at same time each day with or without food
• The pen delivers doses from 10 to 50 units with each injection
Efficacy
• On average HbA1c reduction of 1.9% from baseline to end of trial confirmed to be superior against all comparators1
• On average 2.7 kg weight loss from baseline in patients inadequately controlled on basal insulin
• HbA1c reduction of 1.7% from baseline to end of trial with an estimated treatment difference of -0.5 vs Insulin glargine U100
• Weight gain when converting from liraglutide of 2 kg
Safety
• Hypoglycaemia is the most common adverse reaction • Gastrointestinal adverse reactions may occur more
frequently at the beginning of therapy and diminish within a few days or weeks on continued treatment
• Lower rates of confirmed hypoglycaemia than with insulin degludec in patients on metformin +/- pioglitazone
• Fewer experienced gastrointestinal side effects than patients treated with liraglutide
Source: DUAL I (NN9068-3697), DUAL II (NN9068-3912), DUAL III (NN9068-3851), DUAL IV (NN9068-3952), DUAL V (NN9068-4119)
1 p<0.01
Competitive labels for Xultophy® in both the US and EU
Slide 73
5,05
4,10
3,50
4,72
11,82 11,82
Xultophy® key clinical results
Note: Typical confirmed hypoglycaemia event rates for treatment with basal insulin are 142-369 episodes per 100 PYE (based on insulin glargine event rates from trials NN1250-3586, 3579 and 3672) where the FPG target and hypoglycaemia definition is similar to the DUAL trials
Xultophy® has documented strong efficacy across the treatment cascade
Investor presentation First six months of 2017
DUAL I Add-on to
metformin ± Pio
n = 833
DUAL II Add-on to
metformin ± basal insulin
n = 199
DUAL III Switch from
GLP-1 n = 292
DUAL IV Add-on to SU ± metformin
n = 289
DUAL V Switch from
insulin glargine n = 557
DUAL VI1
Once vs. twice weekly titration N = 420
DUAL VII
IDegLira versus basal-bolus n = 506
Mean trial start HbA1c (%)
8.3 8.7 7.8 7.9 8.4 8.1 8.2
Mean trial end HbA1c (%)
6.4 6.9 6.4 6.4 6.6 6.0 6.7
HbA1c change (%) -1.9 -1.9 -1.3 -1.45 -1.8 -2.0 -1.5
% to target < 7% (%)
80.6 60.3 75.3 79.2 71.6 89.5 66.0
% to target < 6.5% (%)
69.7 45.2 63.0 64.0 55.4 85.0 49.6
Confirmed hypo (Episodes per 100 PYE)
180.2 153.4 282 351.7 343.3 N/A** N/A***
Weight change (kg) -0.5 -2.7 +2.0 +0.5 -1.4 -2.0 -0.9
1 DUAL VI: comparison of IDegLira once weekly vs. twice weekly titration, numbers in table are for IDegLira twice weekly, as this is the titration algorithm which has been applied in all the other DUAL trials.
Slide 74
5,05
4,10
3,50
4,72
11,82 11,82
5.5
6.0
6.5
7.0
7.5
8.0
0 2 4 6 8 10 12 14 16 18 20 22 24 26
-8.0
-6.0
-4.0
-2.0
0.0
0 2 4 6 8 10 12 14 16 18 20 22 24 26
HbA1c reduction from a mean baseline of 7.9% Weight loss from a mean base line of 92 kg
Oral semaglutide reduced HbA1c and body weight in a 26-week phase 2 trial in type 2 diabetes
Inclusion criteria: Type 2 diabetes; 7.0% ≤ HbA1c ≤ 9.5%; treatment with diet and exercise with or without metformin; sc: subcutaneous; sema: semaglutide
Investor presentation First six months of 2017
Placebo Sema 2.5 mg Sema 5 mg Sema 10 mg Sema 20 mg Sema 1 mg sc Sema 40 mg HbA1c (%) Weight loss (kg)
0.0
Time (weeks) Time (weeks)
Slide 75
5,05
4,10
3,50
4,72
11,82 11,82
PIONEER trials for oral semaglutide
Note: Preliminary estimated timing of trials from first patient first visit (FPFV) to last patient last visit (LPLV), n = approximate number of randomised people; MACE: Major Cardiovascular Events; OAD: oral anti-diabetic
2016 2017 2018
PIONEER 1: monotherapy 26 weeks, n=704
PIONEER 2: vs empagliflozin 52 weeks, n=816
PIONEER 3: vs sitagliptin 78 weeks, n=1,860
PIONEER 4: vs liraglutide 52 weeks, n=690
PIONEER 5: moderate renal impairment 26 weeks, n=324
PIONEER 6: cardiovascular outcomes Event driven (>122 MACE), n=3,176
PIONEER 7: flexible dose escalation 52 weeks, n=500
PIONEER 8: insulin add-on 26+26 weeks, n=720
PIONEER 9: JAPAN monotherapy 52 weeks, n=230
PIONEER 10: JAPAN OAD combination 52 weeks, n=336
52 weeks extension trial
Investor presentation First six months of 2017
Slide 76
5,05
4,10
3,50
4,72
11,82 11,82
Rationale
• Elevated hepatic glucose release drives overall higher PPG in people with type 2 diabetes compared to healthy individuals1
• >50% of endogenous insulin secretion is cleared by the liver
• Insulinisation of peripheral tissues with current insulin analogues is higher than for endogenous insulin
Potential benefits
• Mimics physiology of insulin distribution secreted from pancreas
• Less hypoglycaemia
• Less weight gain
Next steps
• Results for phase 1 trial with liver-preferential mealtime insulin (NN1406) expected in Q4 2017
The liver is important for insulin action Rationale and expected benefits of physiologically distributed insulin
Liver-preferential meal time insulin analogue has potential to reduce hypoglycaemia and weight gain
PPG: post prandial glucose 1 Woerle HJ et al. Am J Physiol Endocrinol Metab 2006;290:E67–E77
Investor presentation First six months of 2017
Liver: Glucose production
Muscle: Glucose uptake
Fat: Glucose uptake
sc insulin sc liver-preferential prandial insulin
Endogenous insulin
Note: Mode of action for fast-acting insulin aspart sc: subcutaneous
Slide 77
5,05
4,10
3,50
4,72
11,82 11,82
Insufficient treatment options Significant gaps in obesity treatment
Significant unmet need in obesity management
Source: Diagnosis rate, Practice Fusion March 2014 & Treatment rate, Understanding the Treatment Dynamics of the Obesity Market, IMS Database (NPA), August 2014 * Rx=prescription, ie treated with anti-obesity medication (AOM)
Investor presentation First six months of 2017
All people with obesity
People diagnosed
People Rx treated*
100%
30%
4%
Complexity of treatment Low Medium High
Low
H
igh
Mediu
m
Anti-obesity medication with weight loss of
5-10%
Diet and exercise
Bariatric surgery
Mean weight loss
Slide 78
5,05
4,10
3,50
4,72
11,82 11,82
0
100
200
300
400
500
600
700
2010 2011 2012 2013 2014 2015 2016 2017
Small but growing market for anti-obesity medication in the US
Investor presentation First six months of 2017
Source: IMS NSP Monthly, May 2017
Total anti-obesity market moving-annual market value
AOM value in mUSD
The US obesity burden
1 Finkelstein et al. Health Affairs 28, no. 5 (2009): w822-831 2 Flegal, KM. JAMA. 2012;307(5): Doi:10.1001/jama.2012.39 3 Ma et al. Obesity (Silver Spring) 2009;17:1077–85 4 Obesity. Decision resources, Inc. December 2010:38
• Cost of obesity to health care systems of USD 147 billion annually with continued growth1
• Around 35% of the US adult population (over 20 years) have obesity (BMI>30)2
• Only around 30% of all obesity cases in the US were diagnosed in 20093
• In 2010, only 3 million people in the US or around 3% of the adult population with obesity were treated with anti-obesity medication4
Slide 79
5,05
4,10
3,50
4,72
11,82 11,82
0%
20%
40%
60%
80%
0 5 10 15 20 25
29%
26%
65%
Source: IMS, May 2017 Note: AOM market size varies significantly between countries
Saxenda® value share of anti-obesity medications in selected countries The global obesity potential
Continued global roll-out of Saxenda® and an evolving obesity portfolio
Investor presentation First six months of 2017
78%
7%
USA Canada Brazil
Spain Denmark Italy Germany
Australia Mexico
45% 42%
16% 10%
Months from launch
Saxenda® and obesity pipeline
• Successful uptake of Saxenda® and launch in 19 markets supports Novo Nordisk’s long term commitment to obesity treatment
• EU label update of Saxenda® based on the LEADER trial
• Novo Nordisk obesity pipeline includes semaglutide for obesity in phase 2 and six projects in phase 1
Key global initiatives
• Educate HCPs in obesity management
• Drive patient engagement via Saxenda® care
• Drive recognition of obesity as a chronic disease
• Improve market access to obesity care
Slide 80
5,05
4,10
3,50
4,72
11,82 11,82
Prescription volume uptake of anti-obesity medications (AOM) recently launched in the US Key observations
Steady prescription uptake for Saxenda® in the US
Investor presentation First six months of 2017
• Saxenda® has been launched in 19 markets including the US, Canada, Australia, Russia, UAE, Israel, Germany, Denmark, Sweden, Switzerland, Italy, Spain, Belgium, Luxembourg, UK, Brazil, Chile, Portugal and Mexico
• Saxenda is the leader in value market share at ~49% among the branded AOMs in the US
• While competitors promotional efforts have been erratic, Novo Nordisk remains confident in the long-term obesity market growth and the evolving Novo Nordisk obesity portfolio
TRx Volume (000) Saxenda®
Belviq®
Qsymia®
Contrave®
0
10
20
30
40
50
60
70
80
90
May 2016
24
82
38
33
May 2017
Source: IMS NPA TRx, monthly, May 2017
Slide 81
5,05
4,10
3,50
4,72
11,82 11,82
Saxenda® targeted at patients with BMI ≥35 and weight-related comorbidities
BMI: body mass index 1 Potential lives covered, based on employer opt-ins
Investor presentation First six months of 2017
Aspiration Saxenda® launch execution Saxenda® market approach
Clear product value proposition
Focused prescriber targeting
Focus on engaging prioritised payers and employers
Clear patient segmentation
Build the market
Strengthened by 3-year clinical data
Focus on current prescribers of anti-obesity medication and GLP-1
Formulary coverage emerging with more than 50 million lives1 covered
Focus on patients with BMI ≥35 with weight-related comorbidities
Slide 82
5,05
4,10
3,50
4,72
11,82 11,82
Saxenda® approved in the US for chronic weight management in individuals with a BMI ≥30, or ≥27 in the presence of at least one weight-related comorbidity1
1 Examples include hypertension, type 2 diabetes and dyslipidemia 2 Saxenda® US Package Information. 3 When used with an insulin secretagogue
Competitive US label for Saxenda®
Investor presentation First six months of 2017
• Improvements in cardiometabolic risk factors such as hypertension and dyslipidaemia
• Boxed warning on thyroid C-cell tumours
• Precautions on acute pancreatitis, acute gallbladder disease, serious hypoglycaemia3, heart rate increase, renal impairment, hypersensitivity and suicidal ideation
Profile
Safety
Effect on body weight
Effect on comorbidities
• GLP-1 receptor agonist – a physiological regulator of appetite and calorie intake
• Saxenda® is the first and only GLP-1 receptor agonist approved for weight management
• 9 in 10 lose weight and 1 in 3 people lose more than 10% of their body weight2
• Average weight loss of 9.2% in completers at one year2
Slide 83
5,05
4,10
3,50
4,72
11,82 11,82
Key features of compounds in phase 1 development for obesity
SC: Subcutaneous
Novel obesity compounds in phase 1 development may have complimentary modes of action
Investor presentation First six months of 2017
Phase 1 trial status
Admin
Compound
Mode of action
Expected completion 2018
Once-daily sc injection
NN9838 – Amylin
analogue
Reduced food intake, primarily to be mediated by amylin receptors
Expected completion 2017
Once-daily sc injection in combination with liraglutide
G530S – Glucagon analogue
Stimulation of energy expenditure and satiety
Expected completion 2019
Once-daily sc injection
NN9747 – PYY analogue
Reduced food intake via selective stimulation of the Y2 receptor
Expected completion 2019
Once-daily sc injection
NN9499 – FGF21
analogue
FGF21-induced weight loss presumed to be driven by energy expenditure
Expected completion 2019
Once-weekly sc injection
NN9277 – GG-co-agonist
Stimulation of energy expenditure and satiety
Expected completion 2019
Once-daily sc injection
NN9423 – Tri-agonist 1706
Stimulation of energy expenditure and satiety
Slide 84
5,05
4,10
3,50
4,72
11,82 11,82
Biopharmaceuticals
Investor presentation First six months of 2017
Slide 85
5,05
4,10
3,50
4,72
11,82 11,82
Locations Consequences of bleedings
Haemophilia: Location of bleedings and the consequences
Investor presentation First six months of 2017
• Bleeding in the joint space causes a strong inflammatory reaction which predisposes to further bleeding
• Inadequate or delayed treatment of repeated joint bleeds results in a “target joint”
• The joint is tense, swollen and extremely painful and the mobility is restricted
• Eventually the cartilage erodes completely and permanent joint damage (arthropathy) occurs
• Treatment of arthropathy is orthopaedic surgery
Nose and gums
Joints
Gut
Kidneys
Head and neck
Joints
Joints
Muscles
Joints
Slide 86
5,05
4,10
3,50
4,72
11,82 11,82
Note: The inhibitor segment represents people with haemophilia and high titre inhibitors to their normal replacement treatment Source: Estimates based on prevalence data in literature (Stonebraker JS et al. Haemophilia. 2010; 16: 20-32), World Federation of Haemophilia – Annual Global Survey 2012, UDC database in the US
Number of people with haemophilia A and B and haemophilia with inhibitors
Low diagnosis and treatment rates within haemophilia
Haemophilia is a rare disease with severe unmet medical needs
Source: World Federation of Haemophilia – Annual Global Survey 2016
Investor presentation First six months of 2017
Haemophilia A
App. 350,000 patients
Haemophilia B
App. 70,000 patients
Inhibitor segment app. 3,500-4,000
patients
Average percentage of people with haemophilia
0
100
200
300
400
500
People with
haemophilia
Diagnosed Treated Prophylactic Pristine joints
45%
15%
3% 6%
Number of people (000)
Slide 87
5,05
4,10
3,50
4,72
11,82 11,82
1 Obizur® only indicated for acquired haemophilia 2 CAGR for 5-year period
Sales of recombinant coagulation factors Strategic positioning of Novo Nordisk’s
haemophilia portfolio
Novo Nordisk compound
Status Strategic position
NovoSeven® Launched Maintain market leadership
NovoEight® Launched Establish presence in a competitive market place
N8-GP Phase 33 Contribute to market conversion
Refixia®/ REBINYN® Approved4 Contribute to new treatment
paradigm
NovoThirteen® Launched Launch first recombinant product
Global haemophilia market is growing by high-single digit
3 Submission of N8-GP expected 2018 pending expansion of production capacity 4 Refixia® is the brand name for N9-GP in the EU, and REBINYN® in the US.
Investor presentation First six months of 2017
0
5
10
15
20
25
30
35
2011 2016 2011 2016 2011 2016
DKK billion
rFVIIa rFVIII rFIX
CAGR2: 4% CAGR2: 10% CAGR2: 16%
Xyntha®/Refacto®
NovoSeven®
Kogenate®/Helixate®
Recombinate®/Advate®
Coagil VII® Rixubis®
Obizur®1
Eloctate®
NovoEight®
Alprolix®
Benefix®
Idelvion®
Slide 88
5,05
4,10
3,50
4,72
11,82 11,82
0.0
0.5
1.0
1.5
2.0
2.5
3.0
1 CAGR for 5-year period
NovoSeven® reported quarterly sales Key NovoSeven® properties
NovoSeven® − a unique biologic for the treatment of rare bleeding disorders
2 Only indicated in Europe and the US
Investor presentation First six months of 2017
• Product characteristics: powder and solvent for solution
for intravenous injection, available in multiple doses, stable
at room temperature
• MixPro® administration system launched in 2013
• Indications: treatment of spontaneous and surgical
bleedings in:
• Haemophilia A or B patients with inhibitors
• Acquired haemophilia
• Congenital FVII deficiency
• Glanzmann’s thrombasthenia2
Q2 2012
Q2 2017
DKK billion
CAGR1 (0.5%)
Slide 89
5,05
4,10
3,50
4,72
11,82 11,82
Indications:
• Treatment and prophylaxis of bleeding in patients with congenital factor VIII deficiency for all age groups2
Key product characteristics:
• Reliability: No inhibitor development in PTPs in one of the largest pivotal trial programmes of any approved rFVIII (n=213)2,3
• Purity and safety: First rFVIII to use a 20nm filter in its purification process4
• Portability: Room temperature stability with storage at 30 degrees celsius2
Launch status:
• NovoEight® is available in the US, EU, Japan
• Commercial or technical launch in 27 countries
1 Picture is not intended for promotional purposes
Example from NovoEight® promotional campaign1 NovoEight® properties and launch performance
NovoEight® is launched in the US, Europe and Japan for the treatment of people with haemophilia A
2 NovoEight® Summary of Product Characteristics. 3 Iorio A et al., Blood 2012; 120(4): 720 – 727. 4 NovoEight® Prescribing Information PTP: Previously treated patient
Investor presentation First six months of 2017
Slide 90
5,05
4,10
3,50
4,72
11,82 11,82
R&D pipeline: Haemophilia and growth disorders
1 Submission of N8-GP expected 2018 pending expansion of production capacity
2 Phase 1b trial completed 3 Phase 3 completed in Adult Growth Hormone Deficiency (AGHD) Sc: Subcutanious
Investor presentation First six months of 2017
Product/project Type Indication Status (phase)
1 2 3 Filed Appr.
N9-GP (NN7999) GlycoPEGylated long-acting rFIX Haemophilia B
N8-GP (NN7088)1 GlycoPEGylated long-acting rFVIII Haemophilia A
Concizumab (NN7415)2 Monoclonal anti-TFPI Haemophilia A, B and with inhibitors
Somapacitan (NN8640)3 Once-weekly human growth hormone Growth disorder
Sc N8-GP (NN7170) Sc GlycoPEGylated long-acting rFVIII Haemophilia A
Slide 91
5,05
4,10
3,50
4,72
11,82 11,82
N9-GP administered once-weekly reduces median bleeding rate to 1.0 episode per year in phase 3 trial
Investor presentation First six months of 2017
Dose normalised 50 IU/kg (N=15) One stage clot assay
FIX activity (IU/mL)
N9-GP pdFIX rFIX
1.2
1.0
0.8
0.6
0.4
0.2
0.0
168 0 24 48 72 96 120 144
Time (h)
rFIX: Recombinant factor IX; pdFIX: plasma-derived factor IX Source: Negrier et al. Blood. 2011;115:2693-2701
• Steady-state half life of 110 hours
• Median bleeding rate for patients treated on demand was 15.6 episodes per year
• Patients on once-weekly prophylactic treatment had a medium bleeding rate of 1.0 episode per year when treated with 40 IU/kg
• Among patients receiving 40 IU/kg:
− 99% of bleeding episodes treated with only one infusion
− Two thirds of patients experienced complete resolution of bleeding into target joints
• N9-GP appeared to have a safe and well tolerated profile with no patients developing inhibitors
N9-GP phase 1 pharmacokinetics Paradigm 2 headline results (phase 3)
Slide 92
5,05
4,10
3,50
4,72
11,82 11,82
N8-GP
Source: Tiede et al. J Thromb Haemot. 2013;11:670-675
N8-GP phase 1 pharmacokinetics Pathfinder 2 headline results (phase 3)
N8-GP administered every fourth day reduces median bleeding rate to 1.3 episode per year in phase 3 trial
PK: Pharmacokinetic; ABR: Annualised bleeding rate; IU: International unit 1 Prophylaxis 75 IU/kg every 7 days (n=38) or prophylaxis 50 IU/kg every 4 days (n=17)
Investor presentation First six months of 2017
FVIII activity (IU/mL)
FVIII
Dose 50 IU/kg (n=8) One stage clot assay
1.2
1.0
0.8
0.6
0.4
0.2
0.0
0 24 48 72 96 120 144 168
Time (h)
• PK documented single dose half-life of 18.4 hours and mean trough level before next dose of 3%
• Patients on every fourth day prophylaxis (50 IU/kg) had a median ABR of 1.3
• 95% of mild to moderate bleeds managed with 1-2 doses
• N8-GP appeared to have a safe and well tolerated profile
• One patient developed inhibitors, as expected in a population of previously treated haemophilia A patients
Pathfinder 2 extension trial results
• 55 patients with ≤2 bleeds during 6 months in the main phase were randomised 2:1 to either once-weekly (75 IU/ kg) or every fourth day (50 IU/kg) treatment for 180 days1
• Patients in both treatment arms had a median ABR of 0
Next steps
• Expansion of production capacity; US/EU submission 2018
Slide 93
5,05
4,10
3,50
4,72
11,82 11,82
29%
0%
5%
10%
15%
20%
25%
30%
35%
0
20
40
60
80
100
0
5
10
15
20
Development in global human growth hormone market Human growth hormone volume market share
Novo Nordisk maintains leadership within human growth hormone market
1 CAGR for 5-year period
Source: IMS Monthly MAT May, 2017 volume figures and value (DKK) figures
Source: IMS Monthly MAT May, 2017 volume figures
Investor presentation First six months of 2017
May 2012
May 2017
Sandoz
Roche Eli Lilly
Novo Nordisk Pfizer
Merck Kgaa
May 2012
May 2017
CAGR volume1: 5.9% CAGR value DKK1: 2.2%
MAT value DKK MAT volume kg kg
DKK billion
Slide 94
5,05
4,10
3,50
4,72
11,82 11,82
0.0
0.5
1.0
1.5
2.0
2.5
Norditropin® reported quarterly sales Key Norditropin® properties
Solid Norditropin® sales growth
1 CAGR for 5-year period GHD: Growth Hormone Deficiency; AGHD: Adult growth hormone deficiency SGA: Small for Gestational Age
Investor presentation First six months of 2017
CAGR1 3.3%
• Product characteristics: Premixed, prefilled multi-use
delivery systems available in multiple strengths, and stable
at room temperature
• Expanded indications: GHD, AGHD, Noonan Syndrome,
Turner Syndrome, SGA indication, Idiopathic short stature
• Easy to use FlexPro® device
• Medical and Clinical support programmes
• Patient support programmes
DKK billion
Q2 2012
Q2 2017
Slide 95
5,05
4,10
3,50
4,72
11,82 11,82
Financials
Investor presentation First six months of 2017
Slide 96
5,05
4,10
3,50
4,72
11,82 11,82
0%
10%
20%
30%
2007 2016
0%
10%
20%
30%
2007 2016
Sales growth in local currencies 2007–2016
Operating profit growth in local currencies 2007–2016
Sales have been growing by 11% on average throughout the last decade
Note: Numbers for 2007 and 2008 are adjusted for the impact of the discontinuation of pulmonary insulin projects; Numbers for 2015 and 2016 are adjusted for the non-recurring income related to the partial divestment of NNIT with the dotted component representing this income; average is calculated excluding the effect of the 2015 non-recurring income.
Investor presentation First six months of 2017
11%
Sales growth Average growth Operating profit growth Average growth
18%
Slide 97
5,05
4,10
3,50
4,72
11,82 11,82
Reported annual sales 2012-2016 Reported annual sales split by region
Solid sales growth driven by the US
1 CAGR for 5-year period AAMEO: Africa, Asia, Middle-East and Oceania; J&K: Japan and Korea; LATAM: Latin America
Investor presentation First six months of 2017
Biopharmaceuticals Diabetes
0
20
40
60
80
100
120
1 2 3 4 5
Th
ou
san
ds
2012 2013 2014 2015 2016
CAGR1 9.4%
78% 78%
79% 79%
80%
44% 53%
25% 19%
11% 10% 8% 9% 8% 6%
2012 2016
DKK billion
Region China
Region Europe North America Region AAMEO
Region J&K Region LATAM
Slide 98
5,05
4,10
3,50
4,72
11,82 11,82
7%
41%
9%
20%
4%
9% 6%
2%
Other Diabetes and Obesity Care Reported currencies Sales (mDKK) Sales split
Tresiba® 3,689 6%
Levemir® 7,609 13%
NovoRapid® 10,403 18%
NovoMix® 5,369 9%
Victoza® 11,525 20%
Saxenda® 1,225 2%
Diabetes and obesity care1 47,531 83%
NovoSeven® 4,705 8%
Norditropin® 3,341 6%
Biopharmaceuticals1 9,559 17%
Total1 57,090 100%
Reported sales split by selected key products for the first six months of 2017
Reported sales split by product segments for the first six months of 2017
Victoza® accounts for 20% of total sales in the first six months of 2017
Investor presentation First six months of 2017
Sales of DKK 57.1 billion (+4%)
New-Generation Insulin Human Insulin
Haemophilia Human Growth Hormone
Modern Insulin
GLP-1 Diabetes
Other Biopharmaceuticals
1 Values are higher than the sum of the total elements listed due to residual values from products not listed
Slide 99
5,05
4,10
3,50
4,72
11,82 11,82
0%
10%
20%
30%
40%
50%
60%
0
10
20
30
40
50
60
1 2 3 4 5
Operating profit Operating profit therapy split
Solid operating profit growth driven by diabetes
* Adjusted for the partial divestment of NNIT A/S and inflammatory out-licensing in 2015
Investor presentation First six months of 2017
Diabetes Biopharm
2012 2016
25%
75% 72%
28%
32% 7% 35% 10%
Reported operating profit growth
Operating profit as % of sales Operating profit
2012 2013 2014 2015* 2016*
Operating profit growth in local currencies
20% 15% 13% 13%
DKK billion
6%
4%
Slide 100
5,05
4,10
3,50
4,72
11,82 11,82
Higher profitability in the biopharmaceuticals segment driven by lower COGS and S&D
Investor presentation First six months of 2017
Diabetes & Obesity P&L – full year 2016 Biopharmaceuticals P&L – full year 2016
P&L: Profit and Loss; COGS: Cost of goods sold; OOI: Other operating income; OP: Operating profit S&D: Sales and distribution cost; R&D: research and development cost; Admin: administrative cost
0
20
40
60
80
100
Sales COGS S&D R&D Admin OOI OP
-15%
-28%
-12%
-3% 42% +1%
0
6
12
18
24
30
Sales COGS S&D R&D Admin OOI OP
-12% -17%
-13%
-4% 54% +1%
DKK billion
DKK billion
P&L: Profit and Loss; COGS: Cost of goods sold; OOI: Other operating income; OP: Operating profit S&D: Sales and distribution cost; R&D: research and development cost; Admin: administrative cost
Slide 101
5,05
4,10
3,50
4,72
11,82 11,82
0%
5%
10%
15%
20%
25%
0
5
10
15
20
Th
ou
san
ds
Cost of Goods Sold (COGS) Capital Expenditure (CAPEX)
Stable COGS level as % of sales and increasing CAPEX level
Investor presentation First six months of 2017
2012 2013 2014 2015 2016 0%
1%
2%
3%
4%
5%
6%
7%
8%
0
1
2
3
4
5
6
7
8
1 2 3 4 52012 2013 2014 2015 2016
COGS as % of sales CAPEX as % of sales
COGS CAPEX
DKK billion
DKK billion
Slide 102
5,05
4,10
3,50
4,72
11,82 11,82
0%
10%
20%
30%
40%
Operating profit growth Operating margin
Long term financial targets: Operating profit growth and operating margin
Note: The long term financial targets are based on an assumption of a continuation of the current business environment; 2015 and 2016 figures are adjusted for the partial divestment of NNIT A/S and inflammatory out-licensing in 2015 1 New long term target established in connection with the Q3 2016 report to an average operating profit growth of 5%
2 The target for operating margin was discontinued in connection with the updated long-term financial targets in Q4 2015
Investor presentation First six months of 2017
Previous long term financial targets New long term financial target1
Previous long term financial targets
0%
15%
30%
45%
2012 2013 2014 2015 2016 No Target2
2012 2013 2014 2015 2016
Slide 103
5,05
4,10
3,50
4,72
11,82 11,82
Cash to earnings (three year average)
Long term financial targets: Operating profit after tax to net operating assets and cash to earnings
Operating profit after tax to net operating assets
Investor presentation First six months of 2017
0%
20%
40%
60%
80%
100%
120%
140%
160%
0%
20%
40%
60%
80%
100%
120%
140%
New long term financial target1
Previous long term financial targets
New long term financial target1
Previous long term financial targets
2012 2013 2014 2015 2012 2013 2014 2015 2016 2016
Note: The long term financial targets are based on an assumption of a continuation of the current business environment 1 New long term target established in connection with the Q3 2016 report
Slide 104
5,05
4,10
3,50
4,72
11,82 11,82
Expected future sales drivers Expected future cost drivers
Key assumptions supporting the long term financial target of an average of 5% operating profit growth1
Insulin
• Continued underlying 3-4% volume growth of the global insulin market
• Market share gains and value upgrades driven by the new-generation franchise
Investor presentation First six months of 2017
Obesity
• Continued expansion of the obesity market with Saxenda® in the US
• Successful launches in new markets
Biopharm
• Limited growth of the biopharm franchise mainly due to increased competition in the haemophilia space
• Potential for bolt-on activity to support growth
• 1-3 percentage points decline expected as a result of US pricing impact, partly offset by mix effect and productivity gains
GM
S&D
R&D
Admin
• 2-3 percentage points decline expected in the S&D to sales ratio
• Lower growth in S&D costs mainly driven by focused promotional activities in the US
• Admin to sales ratio expected to decline to around 3%
• Lower growth in admin costs driven by various savings initiatives
• Around 13% R&D to sales ratio expected to remain unchanged
• Refocused research efforts releasing resources to be invested in adjacent disease areas
GM: Gross margin
GLP-1
• Continued expansion of the GLP-1 market with underlying volume growth of >10% annually
• Solid market leadership with Victoza® supported by semaglutide launch (exp 2018)
1 New long term financial target established in connection with the Q3 2016 report. The target of 5% operating profit growth is an average for the period of 4-5 years, with 2015 as the base year.
Slide 105
5,05
4,10
3,50
4,72
11,82 11,82
Cash return priorities and business development activities
Organic growth enables steady cash return to shareholders via dividends and share repurchase programmes
Investor presentation First six months of 2017
Cash return priorities
• Dividend to match pharma peer-group
• Dividend distributed twice a year as interim in August and final in connection with the Annual General Meeting in March the following year
• Share repurchase to at least correspond to remaining cash flow
• The total 2017 programme may be reduced in size, if significant product in-licensing or bolt-on acquisition opportunities are undertaken during 2017
Business development activities
• External academic and business collaborations
• Bolt-on within Biopharm and adjacent disease areas
• Ramp-up in internal organisational capabilities
10 12 13 16
11
14 15
17 8
7
0
5
10
15
20
25
30
35
40
45
2013 2014 2015 2016
16
15
Annual cash return to shareholders
Note: Interim dividend for 2017 of DKK 3.00 per share of DKK 0.20 will be paid in August 2017. For 2017 expected free cash flow is DKK 29-33 billion. Share repurchase programmes run for 12 months starting February until end January of the following year.
DKK billion
Share repurchase Dividend
Free cash flow
Interim dividend
2017
Free cash flow guidance
Slide 106
5,05
4,10
3,50
4,72
11,82 11,82
Note: Treasury shares are included in the capital but have no voting rights
Share structure The Novo Nordisk Foundation
Stable ownership structure - secured through A and B-share structure
Investor presentation First six months of 2017
• The Novo Nordisk Foundation is a self-governing institution that: • provides a stable basis for Novo Nordisk • supports scientific, humanitarian and social purposes
• All strategic and operational matters are governed by the board and management of Novo Nordisk
• Overlapping board memberships ensure that the Novo Nordisk Foundation and Novo Nordisk share vision and strategy
Novo Nordisk A/S
Novo Nordisk Foundation Institutional and private
investors Novo Holding A/S
A shares
537m shares
B shares
1,963m shares
75.5% of votes
28.1% of capital
24.5% of votes
71.9% of capital
Slide 107
5,05
4,10
3,50
4,72
11,82 11,82
The Novo Nordisk Way The Triple Bottom Line Business Principle
Sustainability
Investor presentation First six months of 2017
We build on the purpose set by our founders and live by their values: The Novo Nordisk Way sets the direction and unites us around a common purpose in the pursuit of our aspirations
The Triple Bottom Line Principle guides how we do business responsibly and how we make decisions that consider the interests of stakeholders and the long-term interests of our shareholders
Financially responsible
Socially responsible
Environmentally responsible
Slide 108
5,05
4,10
3,50
4,72
11,82 11,82
Working the Novo Nordisk Way1
2016 performance towards achieving long-term sustainability goals
Operating profit growth
Share of renewable power for production
Investor presentation First six months of 2017
0%
5%
10%
15%
20%
25%
30%
35%
1 Average score in annual employee survey (1-5) 2 2015 and 2016 adjusted for the partial divestment of NNIT A/S and inflammatory out-licensing in 2015 3 Target to be met by 2020 4 Target updated in connection with the Q3 2016 earnings statement
0
1
2
3
4
5
2012 2016 2012 20162
% Scale Growth Realised
Previous Target
0
25
50
75
100
Target
2012 2016
Realised Target3 Realised Target4
Slide 109
5,05
4,10
3,50
4,72
11,82 11,82
Global partnerships to develop an approach to fight urban diabetes
Eight partner cities are addressing the threat of urban diabetes
Cities Changing Diabetes aims to break the ‘Rule of Halves’ and stop urban diabetes from ruining millions of lives
Urban diabetes: Type 2 diabetes in cities
• Map the challenge in selected cities
• Share learning and best practices on how to break the ‘Rule of Halves’
• Drive action plans with local partners
• Identify opportunities for actions beyond the health sector
2/3 of people living
with diabetes live
in urban areas
Mexico City
Copenhagen
Houston
Shanghai
Investor presentation First six months of 2017
Tianjin
Johannesburg
City Leaders
Vancouver
Rome
Slide 110
5,05
4,10
3,50
4,72
11,82 11,82
Employee health and safety and engagement are key focus areas for management
Novo Nordisk is committed to building a diverse and inclusive organisation
Novo Nordisk is committed to the continued development of its employees
FTE: full-time employees 1 Numbers account for FY 2016 vs FY 2015
* All appointments to management positions, incl. internal promotions and external hires, ex. NNIT
Investor presentation First six months of 2017
2012 2016
All managers
Management appointments* Sr. Managers
2012 2016 2012 2016
61%
39% 41%
59% 57%
43%
14%
86%
11%
89%
89.8% retention rate
3.0 accidents per million working hours
4.4 engagement score with the Novo Nordisk Way
41,971 FTE employees and 3% growth vs LY1
57%
43%
Men
Women